Traumatic Brain InjuryHDtDCS-TBINCT04869059
Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
A study testing Transcranial direct current stimulation in people with Traumatic Brain Injury, 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 military veteran participants with histories of traumatic brain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- 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
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 30 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Participants are to be between the ages of 18-75, have previously served in the US armed services, and have had a traumatic brain injury that has led to a verbal retrieval deficit based on neuropsychological testing criteria. Traumatic brain injury must be in the mild to moderate range based on evaluation, including, the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English.
Exclusion Criteria: Exclusion criteria include a history of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, severe traumatic brain injury, post-traumatic stress disorder, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis. Additionally, exclusion criteria include inability to give informed consent; cranial implants or skull defects that affect tDCS administration; and use of medications that interact with or potentially interact with tDCS effects, including, anti-convulsants, amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole, or citalopram.
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
Dallas, Texas, 75235
Ashna Adhikari, 972-883-3161, neurolab.memory@utdallas.edu
Tyler Vintila, 972-883-3161, neurolab.memory@utdallas.edu
About this study
Official title: Treatment of Verbal Retrieval Deficits in Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
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 military veteran participants with histories of traumatic brain injuries. 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 remote traumatic brain injury by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 3-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at 2- and 3-months follow-up testing sessions.
Veterans with histories of traumatic brain injuries 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 after treatment sessions 5, 10, and 15 and two times following treatment competition (i.e., 2-months and 3-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 after treatment sessions 5, 10, and 15 and two times following competition of the second treatment (i.e., 2-months and 3-months).
- Conditions
- Traumatic Brain Injury
- Being tested
- Transcranial direct current stimulation, sham tDCS
- Keywords
- Traumatic brain injury, transcranial direct current stimulation, electroencephalography, cognition, veteran traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
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, 1 milliamp tDCS, High definition tDCS, High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
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 tDCSDevice
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal 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, 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 | 20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions Receives: Device: Transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | 20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions Receives: Device: sham tDCS |
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 3-months Post-Treatment on the Controlled Oral Word Association Test
Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 3-months. Metric: Number of Correct Items Generated
Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Controlled Oral Word Association Test
Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 2-months. Metric: Number of Correct Items Generated
Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
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 3-months Post-Treatment in Category Fluency
Evaluation of treatment group differences in change in Category Fluency from baseline to 3-months. Metric: Number of Correct Items Generated
Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment in Category Fluency
Evaluation of treatment group differences in change in Category Fluency from baseline to 2-months. Metric: Number of Correct Items Generated
Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
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 3-months Post-Treatment on the Semantic Object Retrieval Test
Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 3-months. Metric: Number of Correct Retrievals
Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 in Semantic Object Retrieval Test from baseline to 2-months. Metric: Number of Correct Retrievals
Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.
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 3-months Post-Treatment on the Boston Naming Test
Evaluation of treatment group differences in change in Boston Naming Test from baseline to 3-months. Metric: Number of Correct Names Retrieved
Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 in Boston Naming Test from baseline to 2-months. Metric: Number of Correct Names Retrieved
Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.
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 3-months Post-Treatment on California Verbal Learning Test
Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 3-months. Metric: Number of Correct Retrievals
Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test
Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 2-months. Metric: Number of Correct Retrievals
Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX.
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Secondary outcomes (16)
Treatment group differences in change from Baseline to 3-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 3-months. Metric: Time to Solution
Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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. Metric: Time to Solution
Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
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 3-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 3-months. Metric: Time to Solution
Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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. Metric: Time to Solution
Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
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 3-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 3-months. Metric: Time to Name Items
Delis, D.C., Kaplan, E., \& Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Name Items
Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
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 3-months Post-Treatment on the Digit Span Forward
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 3-months. Metric: Memory Span
Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 in Digit Span Forward from baseline to 2-months. Metric: Memory Span
Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
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 3-months Post-Treatment on the Digit Span Backward
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 3-months. Metric: Memory Span
Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 in Digit Span Backward from baseline to 2-months. Metric: Memory Span
Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
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 3-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 3-months. Metric: Score
Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 in Rey-Osterrieth Complex Figure Test scores from baseline to 2-months. Metric: Score
Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
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 3-months Post-Treatment on the Digit Symbol Substitution Test
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 3-months. Metric: Number of Items
Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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 Digit Symbol Substitution Test from baseline to 2-months. Metric: Number of Items
Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
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 3-months Post-Treatment on the Grooved Pegboard Test
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 3-months. Metric: Completion Time
Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Measured: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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. Metric: Completion Time
Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Aug 2021
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 3-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at 2- and 3-months follow-up testing sessions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 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
- Investigators
- John Hart, MD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869059
- Sponsor's protocol ID
- UTD-TDCSTBI-21-15
- Other IDs
- CDMRP-PT190081, W81XWH-20-1-0846
- Acronym
- HDtDCS-TBI
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2021
- Last updated
- 29 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Verbal Retrieval Deficits in Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT04869059
- Acronym / sponsor ID
- HDtDCS-TBI / UTD-TDCSTBI-21-15
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, transcranial direct current stimulation, electroencephalography, cognition, veteran traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 May 2021 (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 military veteran participants with histories of traumatic brain injuries. 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 remote traumatic brain injury by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 3-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at 2- and 3-months follow-up testing sessions.
Veterans with histories of traumatic brain injuries 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 after treatment sessions 5, 10, and 15 and two times following treatment competition (i.e., 2-months and 3-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 after treatment sessions 5, 10, and 15 and two times following competition of the second treatment (i.e., 2-months and 3-months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, 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 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 3-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at 2- and 3-months follow-up testing sessions.
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulation20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions |
| Sham transcranial direct current stimulation | Sham comparator | Device: sham tDCS20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: tDCS, 1 milliamp tDCS, High definition tDCS, High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10Transcranial 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 tDCSSham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal 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, 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 3-months Post-Treatment on the Controlled Oral Word Association Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 3-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Controlled Oral Word Association Test
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 the Control Word Association Test from baseline to 2-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 3-months Post-Treatment in Category Fluency
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Evaluation of treatment group differences in change in Category Fluency from baseline to 3-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 2-months Post-Treatment in 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 in Category Fluency from baseline to 2-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Semantic Object Retrieval Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 3-months. Metric: Number of Correct Retrievals Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.
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-month Post-Treatment
Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 2-months. Metric: Number of Correct Retrievals Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Boston Naming Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Evaluation of treatment group differences in change in Boston Naming Test from baseline to 3-months. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.
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-month Post-Treatment
Evaluation of treatment group differences in change in Boston Naming Test from baseline to 2-months. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.
Treatment group differences in change from Baseline to 3-months Post-Treatment on California Verbal Learning Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 3-months. Metric: Number of Correct Retrievals Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX.
Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test
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 in California Verbal Learning Test from baseline to 2-months. Metric: Number of Correct Retrievals Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX.
16 secondary outcomes
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part A)
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part B)
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Forward
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Backward
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Symbol Substitution Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month Post-Treatment
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Grooved Pegboard Test
Time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month 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-month 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 29 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, 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 Traumatic Brain Injury, 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?
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 29 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 Tyler Vintila (972-883-3161, neurolab.memory@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 3-months Post-Treatment on the Controlled Oral Word Association Test (time frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment). The study lists 10 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 29 Sep 2026.