Multiple SclerosisMS-LIFG-HDtDCSNCT07914257
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
A study testing High Definition transcranial Direct Current Stimulation in people with Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis (RRMS), run by The University of Texas at Dallas at 1 site in United States.
Trial summary
The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
- What is being tested?
- High Definition transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be between the ages of 18 and 64;
- Participants must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS). A physician's note verifying RRMS will be required if they are a patient outside the UT Southwestern network;
- Participants must have a validated memory deficit: Validation will be done via neuropsychological testing at the initial/baseline visit using the Semantic Object Retrieval Test (SORT), COWAT (letter and category fluency), Boston Naming Test (BNT), and Auditory Verbal Learning Test (AVLT); neuropsychological test score on at least one verbal retrieval assessment (COWAT, BNT, AVLT) of a T-score less than 40 or a verbal retrieval test that was greater than 1.0 SD below the average T-score on SORT;
- Participants must be fluent in speaking and reading English because testing materials are not available in other languages.
Who cannot join
- Relapse or acute MS exacerbation during the two months (60 days) preceding the baseline testing, with re-evaluation for inclusion possible after the 60 days of stability;
- Less than 3 months (90 days) on a stable dose of benzodiazepines or modaphinil/armodafinil;
- A history of a neurological disorder, other than RRMS, including dementia of any type, epilepsy or other seizure disorders, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, or - - Huntington's disease;
- Epilepsy or other seizure disorder;
- Severe traumatic brain injury;
- Unexplained episodes of loss of consciousness;
Show all 22Show fewer
- Suffering frequent headaches;
- Unstable or uncontrolled psychiatric illness;
- Brain tumor;
- Serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;
- Stroke;
- Head implant or skull defects/damage that would affect HDtDCS administration or EEG recording;
- Use of brain medical device;
- Cardiac, neural, or medication implants that would affect HDtDCS administration or EEG recording;
- Vascular clip;
- Scalp skin condition like dermatitis, psoriasis, or eczema;
- Current substance abuse, less than 1 year of discontinuation; Pregnancy;
- Cognitive impairment due to an issue other than RRMS;
- Telephone-administered Montreal Cognitive Assessment (TMoCA) Score <19, unless accompanied by a legally authorized representative (LAR) to the consenting session;
- Montreal Cognitive Assessment (MoCA) Score <23, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent; Not being able to give informed consent, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent, and with consent ability assessed with a set of comprehension questions regarding the study and consenting to participate and with MoCA criteria above;
- Medication Restrictions: Certain medications can temporarily change how your brain responds to electrical stimulation or affect EEG signals, and therefore are exclusionary: 1) Known medications that interact with tDCS efficacy: anti-convulsants, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole; 2) Medications that lower the seizure threshold; 3) Stimulant Medications (e.g., Adderall, Ritalin, often used for MS-related fatigue) cannot be taken during the course of the study; enrollment can be considered if the participant is willing to suspend use over the course of the study and suspension is coordinated with the prescribing physician); suspension must occur at least 3 days before any assessment session and must be maintained over the HDtDCS treatment phases of the study;
- Steroid Medications (e.g., Prednisone, Decadron, IV Solu-Medrol, often used for MS relapses or inflammation treatment); If a participant has taken prescription steroid pills or received a steroid IV, they must wait at least 2 months (60 days) after your last dose before you can start tDCS treatments, although baseline testing will permissible within this 2-month waiting period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Callier Clinical Researcher Center
Richardson, Texas, 75080
Tyler Vintila, MS, 972-833-3161, Tyler.Vintila@UTDallas.edu
Jill Ritter, BA, 972-833-3161, jill.ritter@utdallas.edu
About this study
The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.
Read the detailed description
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with multiple sclerosis by comparing (1) 1 milliamp of High Definition transcranial Direct Current Stimulation (HDtDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions to (2) sham HDtDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, participants will complete a second set of 10 sessions where they will switch conditions (i.e., those who received active stimulation will be switched to sham, and vice versa), and the will be re-evaluated at immediate and 2-month follow-up testing sessions.
Patients with multiple sclerosis and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected at baseline and two times following each treatment competition (i.e., immediate and 2-months).
- Being tested
- High Definition transcranial Direct Current Stimulation, Sham High Definition transcranial Direct Current Stimulation
- Keywords
- transcranial direct current stimulation (tDCS), multiple sclerosis, relapsing-remitting multiple sclerosis, electroencephalography, treatment trial
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Definition transcranial Direct Current StimulationDevice
Also called HDtDCS, High Definition tDCS, Neuroelectrics Starstim tES
High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
Sham High Definition transcranial Direct Current StimulationDevice
Also called sham, sham tDCS, sham HDtDCS
Sham High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. The setup will consist of placing electrodes at F7, T7, FP, AF3, and FC5 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp back down to 0 milliamps over 60 seconds, and then remain at 0 milliamps over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High Definition transcranial Direct Current Stimulation | Experimental | High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Receives: Device: High Definition transcranial Direct Current Stimulation |
| Sham High Definition transcranial Direct Current Stimulation | Sham comparator | Sham High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. The setup will consist of placing electrodes at F7, T7, FP, AF3, and FC5 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp back down to 0 milliamps over 60 seconds, and then remain at 0 milliamps over 20 minutes. Receives: Device: Sham High Definition transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
Evaluation of treatment arm differences in change in Category Fluency following treatment Period 1. Category Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement.
Metric: Number of Correct Items Generated
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Category Fluency
Evaluation of treatment arm differences in change in Category Fluency following treatment Period 2. Category Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Verbal Fluency
Evaluation of treatment arm differences in change in Verbal Fluency following treatment Period 1. Verbal Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Verbal Fluency
Evaluation of treatment arm differences in change in Verbal Fluency following treatment Period 2. Verbal Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Secondary outcomes (52)
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Auditory Verbal Learning Test Delayed Memory
Evaluation of treatment arm differences in change in Auditory Verbal Learning Test delayed memory following treatment Period 1. The Auditory Verbal Learning Test is a standardized list-learning test, where higher scores indicate memory improvement. Metric: Number of Correct Items Recalled
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Auditory Verbal Learning Test Delayed Memory
Evaluation of treatment arm differences in change in Auditory Verbal Learning Test delayed memory following treatment Period 2. The Auditory Verbal Learning Test is a standardized list-learning test, where higher scores indicate memory improvement. Metric: Number of Correct Items Recalled
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 Picture Description Test Words Per Minute
Evaluation of treatment arm differences in change in the Picture Description Test words per minute following treatment Period 1. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate word per minute improvement. Metric: Number of Words per Minute
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Period Picture Description Test Words Per Minute
Evaluation of treatment arm differences in change in the Picture Description Test words per minute following treatment Period 2. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate word per minute improvement. Metric: Number of Words per Minute
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Main Concepts Score
Evaluation of treatment arm differences in change in the Picture Description Test main concepts following treatment Period 1. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater main concept identification improvement. Metric: Number of Main Concepts
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Main Concept Scores
Evaluation of treatment arm differences in change in the Picture Description Test main concepts following treatment Period 2. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater main concept identification improvement. Metric: Number of Main Concepts
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Core Lexicon Score
Evaluation of treatment arm differences in change in the Picture Description Test Core Lexicon Score following treatment Period 1. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater Core Lexicon use. Metric: Core Lexicon Production
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
12. Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Core Lexicon Score
Evaluation of treatment arm differences in change in the Picture Description Test Core Lexicon Score following treatment Period 2. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater Core Lexicon use. Metric: Core Lexicon Production
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Boston Naming Test Score
Evaluation of treatment arm differences in change in confrontational naming scores on the Boston Naming Test following treatment Period 1. The Boston Naming Test is a standardized assessment with scoring rules, where higher scores indicate confrontational naming improvement. Metric: Number of Items Named Correctly
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Boston Naming Test Score
Evaluation of treatment arm differences in change in confrontational naming scores on the Boston Naming Test following treatment Period 2. The Boston Naming Test is a standardized assessment with scoring rules, where higher scores indicate confrontational naming improvement. Metric: Number of Items Named Correctly
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Semantic Object Retrieval Test
Evaluation of treatment arm differences in change in Semantic Object Retrieval following treatment Period 1. The Semantic Object Retrieval Test is a standardized assessment with scoring rules, where higher scores indicate memory retrieval improvement. Metric: Number of Correct Names Retrieved
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Semantic Object Retrieval Test
Evaluation of treatment arm differences in change in Semantic Object Retrieval following treatment Period 1. The Semantic Object Retrieval Test is a standardized assessment with scoring rules, where higher scores indicate memory retrieval improvement. Metric: Number of Correct Names Retrieved
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Delis-Kaplan Executive Function System Color Word Interference Test
Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference Test following treatment Period 1. The Color word Interference Test is a timed assessment with standardized scoring rules, where higher scores indicate inhibitory control improvement. Metric: Number of Items Correctly Named
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Delis-Kaplan Executive Function System Color Word Interference Test
Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference Test following treatment Period 2. The Color word Interference Test is a timed assessment with standardized scoring rules, where higher scores indicate inhibitory control improvement. Metric: Number of Items Correctly Named
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference-Switching Test following treatment Period 1. The Color word Interference-Switching Test is a timed assessment with standardized scoring rules, where higher scores indicate cognitive (switching) control improvement. Metric: Number of Items Correctly Named
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference-Switching Test following treatment Period 2. The Color word Interference-Switching Test is a timed assessment with standardized scoring rules, where higher scores indicate cognitive (switching) control improvement. Metric: Number of Items Correctly Named
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Trail Making Test: Part A
Evaluation of treatment arm differences in change in Trail Making Test Part A reaction time following treatment Period 1. Trail Making Test Part A is a timed assessment with standardized scoring rules, where higher scores indicate speed improvement. Metric: Time to Solution
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on Trail Making Test: Part A
Evaluation of treatment arm differences in change in Trail Making Test Part A reaction time following treatment Period 2. Trail Making Test Part A is a timed assessment with standardized scoring rules, where higher scores indicate speed improvement. Metric: Time to Solution
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on Trail Making Test: Part B
Evaluation of treatment arm differences in change in Trail Making Test Part B reaction time following treatment Period 1. Trail Making Test Part B is a timed assessment with standardized scoring rules, where higher scores indicate switching speed improvement. Metric: Time to Solution
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Trail Making Test: Part B
Evaluation of treatment arm differences in change in Trail Making Test Part B reaction time following treatment Period 2. Trail Making Test Part B is a timed assessment with standardized scoring rules, where higher scores indicate switching speed improvement. Metric: Time to Solution
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Forward
Evaluation of treatment arm differences in change in Digit Span Forward following treatment Period 1. Digit Span Forward is standardized assessment of working memory span, where higher scores indicate working memory improvement. Metric: Memory Span
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Digit Span Forward
Evaluation of treatment arm differences in change in Digit Span Forward following treatment Period 2. Digit Span Forward is standardized assessment of working memory span, where higher scores indicate working memory improvement. Metric: Memory Span
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Backward
Evaluation of treatment arm differences in change in Digit Span Backward following treatment Period 1. Digit Span Backward is standardized assessment of working memory manipulation span, where higher scores indicate working memory improvement. Metric: Memory Span
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Digit Span Backward
Evaluation of treatment arm differences in change in Digit Span Backward following treatment Period 2. Digit Span Backward is standardized assessment of working memory manipulation span, where higher scores indicate working memory improvement. Metric: Memory Span
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Wisconsin Card Sort Categories Achieved
Evaluation of treatment arm differences in change in Wisconsin Card Sort categories achieved following treatment Period 1. Wisconsin Card Sort is a standardized assessment with scoring rules, where higher scores indicate executive function improvement. Metric: Number of Sort Categories Achieved
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Wisconsin Card Sort Categories Achieved
Evaluation of treatment arm differences in change in Wisconsin Card Sort categories achieved following treatment Period 2. Wisconsin Card Sort is a standardized assessment with scoring rules, where higher scores indicate executive function improvement. Metric: Number of Sort Categories Achieved
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Judgment of Line Orientation
Evaluation of treatment arm differences in change in Judgment of Line Orientation accuracy following treatment Period 1. Judgment of Line Orientation is a standardized assessment of visuo-spatial ability, where higher scores indicate visuo-spatial ability improvement. Metric: Number of Problems Solved Correctly
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Judgment of Line Orientation
Evaluation of treatment arm differences in change in Judgment of Line Orientation accuracy following treatment Period 2. Judgment of Line Orientation is a standardized assessment of visuo-spatial ability, where higher scores indicate visuo-spatial ability improvement. Metric: Number of Problems Solved Correctly
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Grooved Pegboard Test
Evaluation of treatment arm differences in change in Grooved Pegboard performance following treatment Period 1. The Grooved Pegboard test is a timed, standardized assessment of visuo-motor ability, where higher scores indicate visuo-motor ability improvement. Metric: Completion Time
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Grooved Pegboard Test
Evaluation of treatment arm differences in change in Grooved Pegboard performance following treatment Period 2. The Grooved Pegboard test is a timed, standardized assessment of visuo-motor ability, where higher scores indicate visuo-motor ability improvement. Metric: Completion Time
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Paced Auditory Serial Addition Test
Evaluation of treatment arm differences in change in Paced Auditory Serial Addition accuracy following treatment Period 1. The Paced Auditory Serial Addition Test is a timed assessment with standardized scoring rules, where higher scores indicate speed of processing improvement. Metric: Number of Correct Responses
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the on the Paced Auditory Serial Addition Test
Evaluation of treatment arm differences in change in Paced Auditory Serial Addition accuracy following treatment Period 2. The Paced Auditory Serial Addition Test is a timed assessment with standardized scoring rules, where higher scores indicate speed of processing improvement. Metric: Number of Correct Responses
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Brief Visual Memory Test
Evaluation of treatment arm differences in change in Brief Visual Memory Test delayed recall following treatment Period 1. The Brief Visual Memory Test is a standardized assessment with scoring rules, where higher scores indicate visual memory improvement. Metric: Number of Items Correctly Recalled
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Brief Visual Memory Test
Evaluation of treatment arm differences in change in Brief Visual Memory Test delayed recall following treatment Period 2. The Brief Visual Memory Test is a standardized assessment with scoring rules, where higher scores indicate visual memory improvement. Metric: Number of Items Correctly Recalled
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Digit Symbol Substitution Test
Evaluation of treatment arm differences in change in Digit Symbol Substitution accuracy following treatment Period 1. The Digit Symbol Substitution Test is a timed assessment with standardized scoring rules, where higher scores indicate processing speed improvement. Metric: Number of Correct Items
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Digit Symbol Substitution Test
Evaluation of treatment arm differences in change in Digit Symbol Substitution accuracy following treatment Period 2. The Digit Symbol Substitution Test is a timed assessment with standardized scoring rules, where higher scores indicate processing speed improvement. Metric: Number of Correct Items
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Rey-Osterrieth Complex Figure Test
Evaluation of treatment arm differences in change in Rey-Osterrieth Complex Figure memory following treatment Period 1. Rey-Osterrieth Complex Figure Test is a standardized assessment with scoring rules, where higher scores indicate visuo-spatial memory improvement. Metric: Recall Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Rey-Osterrieth Complex Figures Test
Evaluation of treatment arm differences in change in Rey-Osterrieth Complex Figure memory following treatment Period 2. Rey-Osterrieth Complex Figure Test is a standardized assessment with scoring rules, where higher scores indicate visuo-spatial memory improvement. Metric: Recall Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the MS Quality of Life Assessment
Evaluation of treatment arm differences in change in MS Quality of Life Assessment Mental Health Composite score following treatment Period 1. MS Quality of Life Assessment is a standardized self-assessment questionnaire with scoring rules, where higher scores indicate mental health improvement. Metric: Mental Health Composite Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the MS Quality of Life Assessment Mental Health Composite
Evaluation of treatment arm differences in change in MS Quality of Life Assessment Mental Health Composite score following treatment Period 2. MS Quality of Life Assessment is a standardized self-assessment questionnaire with scoring rules, where higher scores indicate mental health improvement. Metric: Mental Health Composite Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Modified Fatigue Impact Scale
Evaluation of treatment arm differences in change on the Modified Fatigue Impact Scale following treatment Period 1. Modified Fatigue Impact Scale is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate fatigue improvement. Metric: Total Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Modified Fatigue Impact Scale
Evaluation of treatment arm differences in change on the Modified Fatigue Impact Scale following treatment Period 2. Modified Fatigue Impact Scale is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate fatigue improvement. Metric: Total Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Perceived Deficits Questionnaire
Evaluation of treatment arm differences in change on the Perceived Deficits Questionnaire following treatment Period 1. The Perceived Deficits Questionnaire is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate deficit improvement. Metric: Total Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Perceived Deficits Questionnaire
Evaluation of treatment arm differences in change on the Perceived Deficits Questionnaire following treatment Period 2. The Perceived Deficits Questionnaire is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate deficit improvement. Metric: Total Score
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG P3 event-related potential on the Semantically Cued Inhibition Task
Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantically Cued Inhibition Task following treatment Period 1. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where P3 event-related potential is measured at 300-600 ms post-stimulus onset. Metric: microvolts
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG P3 event-related potential on the Semantically Cued Inhibition Task
Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantically Cued Inhibition Task following treatment Period 2. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where P3 event-related potential is measured at 300-600 ms post-stimulus onset. Metric: microvolts
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG spectral power on the Semantically Cued Inhibition Task
Evaluation of treatment arm differences in change in EEG spectral power on the Semantically Cued Inhibition Task following treatment Period 1. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB)
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG spectral power on the Semantically Cued Inhibition Task
Evaluation of treatment arm differences in change in EEG spectral power on the Semantically Cued Inhibition Task following treatment Period 2. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB)
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG late event-related potential on the Semantic Object Retrieval Task
Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantic Object Retrieval Task following treatment Period 1. The Semantically Object Retrieval Task is a measure of object retrieval, where the late event-related potential is measured after 700 ms post-stimulus onset. Metric: microvolts
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG late event-related potential on the Semantic Object Retrieval Task
Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantic Object Retrieval Task following treatment Period 2. The Semantically Object Retrieval Task is a measure of object retrieval, where the late event-related potential is measured after 700 ms post-stimulus onset. Metric: microvolts
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG spectral power on the Semantic Object Retrieval Task
Evaluation of treatment arm differences in change in EEG spectral power on the Semantic Object Retrieval Task following treatment Period 1. The Semantically Object Retrieval Task is a measure of object retrieval, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB)
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG spectral power on the Semantic Object Retrieval Task
Evaluation of treatment arm differences in change in EEG spectral power on the Semantic Object Retrieval Task following treatment Period 2. The Semantically Object Retrieval Task is a measure of object retrieval, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB)
Measured: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp High Definition transcranial Direct Current Stimulation (HDtDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions to (2) sham HD tDCS following the same schedule. After completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, participants will complete another set 10 sessions, also 20 minutes, where the participants initially assigned to receive sham treatment will receive the active treatment, and vice versa. Participants will then be re-evaluated at immediate- and 2-months follow-up testing sessions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Hart, Jr., The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914257
- Sponsor's protocol ID
- IRB-26-579
- Other IDs
- RG-2601-46141
- Acronym
- MS-LIFG-HDtDCS
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT07914257
- Acronym / sponsor ID
- MS-LIFG-HDtDCS / IRB-26-579
- Keywords
- transcranial direct current stimulation (tDCS), multiple sclerosis, relapsing-remitting multiple sclerosis, electroencephalography, treatment trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.
Detailed description
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with multiple sclerosis by comparing (1) 1 milliamp of High Definition transcranial Direct Current Stimulation (HDtDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions to (2) sham HDtDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, participants will complete a second set of 10 sessions where they will switch conditions (i.e., those who received active stimulation will be switched to sham, and vice versa), and the will be re-evaluated at immediate and 2-month follow-up testing sessions.
Patients with multiple sclerosis and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected at baseline and two times following each treatment competition (i.e., immediate and 2-months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp High Definition transcranial Direct Current Stimulation (HDtDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions to (2) sham HD tDCS following the same schedule. After completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, participants will complete another set 10 sessions, also 20 minutes, where the participants initially assigned to receive sham treatment will receive the active treatment, and vice versa. Participants will then be re-evaluated at immediate- and 2-months follow-up testing sessions.
| Arm | Type | Receives |
|---|---|---|
| High Definition transcranial Direct Current Stimulation | Experimental | Device: High Definition transcranial Direct Current StimulationHigh Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. |
| Sham High Definition transcranial Direct Current Stimulation | Sham comparator | Device: Sham High Definition transcranial Direct Current StimulationSham High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. The setup will consist of placing electrodes at F7, T7, FP, AF3, and FC5 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp back down to 0 milliamps over 60 seconds, and then remain at 0 milliamps over 20 minutes. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be between the ages of 18 and 64;
- Participants must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS). A physician's note verifying RRMS will be required if they are a patient outside the UT Southwestern network;
- Participants must have a validated memory deficit: Validation will be done via neuropsychological testing at the initial/baseline visit using the Semantic Object Retrieval Test (SORT), COWAT (letter and category fluency), Boston Naming Test (BNT), and Auditory Verbal Learning Test (AVLT); neuropsychological test score on at least one verbal retrieval assessment (COWAT, BNT, AVLT) of a T-score less than 40 or a verbal retrieval test that was greater than 1.0 SD below the average T-score on SORT;
- Participants must be fluent in speaking and reading English because testing materials are not available in other languages.
Key exclusion criteria (22 listed)
- Relapse or acute MS exacerbation during the two months (60 days) preceding the baseline testing, with re-evaluation for inclusion possible after the 60 days of stability;
- Less than 3 months (90 days) on a stable dose of benzodiazepines or modaphinil/armodafinil;
- A history of a neurological disorder, other than RRMS, including dementia of any type, epilepsy or other seizure disorders, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, or - - Huntington's disease;
- Epilepsy or other seizure disorder;
- Severe traumatic brain injury;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Definition transcranial Direct Current StimulationAlso: HDtDCS, High Definition tDCS, Neuroelectrics Starstim tESHigh Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. | Device | High Definition transcranial Direct Current Stimulation |
| Sham High Definition transcranial Direct Current StimulationAlso: sham, sham tDCS, sham HDtDCSSham High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. The setup will consist of placing electrodes at F7, T7, FP, AF3, and FC5 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp back down to 0 milliamps over 60 seconds, and then remain at 0 milliamps over 20 minutes. | Device | Sham High Definition transcranial Direct Current Stimulation |
Primary outcome
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Evaluation of treatment arm differences in change in Category Fluency following treatment Period 1. Category Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Category Fluency
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Evaluation of treatment arm differences in change in Category Fluency following treatment Period 2. Category Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Verbal Fluency
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Evaluation of treatment arm differences in change in Verbal Fluency following treatment Period 1. Verbal Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Verbal Fluency
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Evaluation of treatment arm differences in change in Verbal Fluency following treatment Period 2. Verbal Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated
52 secondary outcomes
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Auditory Verbal Learning Test Delayed Memory
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Auditory Verbal Learning Test Delayed Memory
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 Picture Description Test Words Per Minute
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Period Picture Description Test Words Per Minute
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Main Concepts Score
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Main Concept Scores
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Core Lexicon Score
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
12. Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Core Lexicon Score
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Boston Naming Test Score
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Boston Naming Test Score
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Semantic Object Retrieval Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Semantic Object Retrieval Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Delis-Kaplan Executive Function System Color Word Interference Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Delis-Kaplan Executive Function System Color Word Interference Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Trail Making Test: Part A
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on Trail Making Test: Part A
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on Trail Making Test: Part B
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Trail Making Test: Part B
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Forward
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Digit Span Forward
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Backward
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Digit Span Backward
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Wisconsin Card Sort Categories Achieved
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Wisconsin Card Sort Categories Achieved
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Judgment of Line Orientation
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Judgment of Line Orientation
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Grooved Pegboard Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Grooved Pegboard Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Paced Auditory Serial Addition Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the on the Paced Auditory Serial Addition Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Brief Visual Memory Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Brief Visual Memory Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Digit Symbol Substitution Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Digit Symbol Substitution Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Rey-Osterrieth Complex Figure Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Rey-Osterrieth Complex Figures Test
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the MS Quality of Life Assessment
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the MS Quality of Life Assessment Mental Health Composite
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Definition transcranial Direct Current Stimulation in people with Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis (RRMS), run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency (time frame: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.