Multiple Sclerosis, Relapsing-RemittingMS-HDtDCSNCT05958381
Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
A study testing Transcranial Direct Current Stimulation in people with Multiple Sclerosis, Relapsing-Remitting, 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 transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) 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 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 29 Jun 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- º Diagnosed with relapsing-remitting multiple sclerosis (RRMS)
- º Memory retrieval deficit based on neuropsychological testing done in our lab
- º Must be fluent in speaking and reading English.
Who cannot join
- º Relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing
- º Participants using benzodiazepines must have been on a stable dose for at least two months
- º Potentially confounding psychological or neurological disorder, including:
- dementia of any type
- epilepsy or other seizure disorders
- severe traumatic brain injury
Show all 28Show fewer
- brain tumor
- present drug abuse
- stroke
- blood vessel abnormalities in the brain
- Parkinson's disease
- Huntington's disease
- º inability to give informed consent
- º cranial implants
- º skull defects that affect tDCS administration
- º use of medications that interact with or potentially interact with tDCS effects, including:
- anti-convulsants
- L-dopa
- carbamazepine
- sulpiride
- pergolide
- lorazepam
- rivastigmine
- dextromethorphan
- D-cycloserine
- flunarizine
- ropinirole
- stimulants (dextroamphetamine/amphetamine/modafinil/armodafinil) must be stopped during enrollment
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, 1 recruiting
- Recruiting
The University of Texas at Dallas
Richardson, Texas, 75080
Jill Ritter, BS, 972-833-3161, neurolab.memory@utdallas.edu
About this study
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) 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. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
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 transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and 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 at baseline and two times following treatment competition (i.e., immediate and 2-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again two times immediately following completion of the last treatment and 2-months afterward.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Transcranial Direct Current Stimulation, Sham transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation (tDCS), multiple sclerosis, electroencephalography (EEG)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via 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 transcranial direct current stimulationDevice
Also called Sham tDCS
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement) . All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via 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.
Other Names:
tDCS
1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10 Receives: Device: Transcranial Direct Current Stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes. Receives: Device: Sham 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 1-week Post-Treatment on Category Fluency
Evaluation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment.
Metric: Number of Correct Items Generated
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment.
Metric: Number of Correct Items Generated
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT
Evaluation of treatment group differences in change on COWAT from baseline to 1-week post-treatment.
Metric: Number of Correct Items Generated
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT
Evaluation of treatment group differences in change on COWAT from baseline to 2-months post-treatment.
Metric: Number of Correct Items Generated
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Secondary outcomes (30)
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A)
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 1-week post-treatment.
Metric: Time to Solution
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B)
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 1-week post-treatment.
Metric: Time to Solution
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 1-week post-treatment.
Metric: Time to Name Items
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward
Evaluation of treatment group differences in change on the on the Digit Span Forward from baseline to 1-week post treatment.
Metric: Memory Span
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward
Evaluation of treatment group differences in change on the Digit Span Backward from baseline to 1-week post treatment.
Metric: Memory Span
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test
Evaluation of treatment group differences in change on the Rey-Osterrieth Complex Figure Test from baseline to 1-week post treatment.
Metric: Score
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test
Evaluation of treatment group differences in change on the on the the Digit Symbol Substitution Test from baseline to 1-week post treatment.
Metric: Number of Items
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 1-week post-treatment.
Metric: Completion Time
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test
Evaluation of treatment group differences in change on the Semantic Object Retrieval Test from baseline to 1-week post-treatment.
Metric: Number of Correct Names Retrieved
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test
Evaluation of treatment group differences in change on the Boston Naming Test from baseline to 1-week post-treatment.
Metric: Number of Items Correctly Named
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test
Evaluation of treatment group differences in change on the Auditory Verbal Learning Test from baseline to 1-week post-treatment.
Metric: Number of Items Remembered
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 2-months post-treatment.
Metric: Time to Solution
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months post-treatment.
Metric: Time to Solution
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 2-months post-treatment.
Metric: Time to Name Items
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
Evaluation of treatment group differences in change on the on the Digit Span Forward from baseline to 2-months post-treatment.
Metric: Memory Span
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
Evaluation of treatment group differences in change on the on the Digit Span Backward from baseline to 2-months post-treatment.
Metric: Memory Span
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Evaluation of treatment group differences in change on the on the Rey-Osterrieth Complex Figure Test from baseline to 2-months post-treatment.
Metric: Score
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test
Evaluation of treatment group differences in change on the on the the Digit Symbol Substitution Test from baseline to 2-months post treatment.
Metric: Number of Items
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 2-months post-treatment.
Metric: Completion Time
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test
Evaluation of treatment group differences in change on the Semantic Object Retrieval Test from baseline to 2-months post-treatment.
Metric: Number of Correct Names Retrieved
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
Evaluation of treatment group differences in change on the Boston Naming Test from baseline to 2-months post-treatment.
Metric: Number of Items Correctly Named
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Auditory Verbal Learning Test
Evaluation of treatment group differences in change on the Auditory Verbal Learning Test from baseline to 2-months post-treatment.
Metric: Number of Items Remembered
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG spectral power
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 1-week post-treatment.
Metric: EEG spectral (theta) power
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG spectral power
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 2-months post-treatment.
Metric: EEG spectral (theta) power
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 1-week post-treatment.
Metric: EEG N2/P3 event-related potential amplitude
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 2-months post-treatment.
Metric: EEG N2/P3 event-related potential amplitude
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG spectral power
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 1-week post-treatment.
Metric: EEG spectral (theta) power
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG spectral power
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 2-months post-treatment.
Metric: EEG event-related potential amplitude
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG event-related potential
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 1-week post-treatment.
Metric: EEG late-onset (750 ms) event-related potential
Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG event-related potential
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 2-months post-treatment.
Metric: EEG late-onset (750 ms) event-related potential
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start18 Oct 2023
- Primary completion29 Jun 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Parallel groups
- Model description
- Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be and re-evaluated at immediate- and 2-months follow-up testing sessions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, John Hart, Jr., The University of Texas at Dallas
- Investigators
- John Hart, Jr, MD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958381
- Sponsor's protocol ID
- 23-521
- Other IDs
- HT94252310618, E04675.1a
- Acronym
- MS-HDtDCS
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT05958381
- Acronym / sponsor ID
- MS-HDtDCS / 23-521
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- transcranial direct current stimulation (tDCS), multiple sclerosis, electroencephalography (EEG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 24 Jul 2023 (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 transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) 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. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
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 transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and 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 at baseline and two times following treatment competition (i.e., immediate and 2-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again two times immediately following completion of the last treatment and 2-months afterward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be and re-evaluated at immediate- and 2-months follow-up testing sessions.
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Device: Transcranial Direct Current StimulationTranscranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via 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. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10 |
| Sham transcranial direct current stimulation | Sham comparator | Device: Sham transcranial direct current stimulationSham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- º Diagnosed with relapsing-remitting multiple sclerosis (RRMS)
- º Memory retrieval deficit based on neuropsychological testing done in our lab
- º Must be fluent in speaking and reading English.
Key exclusion criteria (28 listed)
- º Relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing
- º Participants using benzodiazepines must have been on a stable dose for at least two months
- dementia of any type
- epilepsy or other seizure disorders
- 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 |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSTranscranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via 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 | Transcranial direct current stimulation |
| Sham transcranial direct current stimulationAlso: Sham tDCSSham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement) . All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes. | Device | Sham transcranial direct current stimulation |
Primary outcome
Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated
Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated
Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change on COWAT from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated
Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on COWAT from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated
30 secondary outcomes
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A)
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B)
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Auditory Verbal Learning Test
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG spectral power
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG spectral power
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG spectral power
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG spectral power
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG event-related potential
Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG event-related potential
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
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 15 Sep 2026.
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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.
John Hart, Jr, MD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Multiple Sclerosis, Relapsing-Remitting, 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 3 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 15 Sep 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?
Contact Ashna Adhikari, MS (972-833-3161, Ashna.Adhikari@UTDallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency (time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment). 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 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.