An interventional study of Active Transcranial direct current stimulation and Sham Transcranial direct current stimulation in Traumatic Brain Injury, Cognitive Change and Word Finding Difficulty, sponsored by The University of Texas at Dallas. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment
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., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-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, concussion history, structural brain imaging, and EEG predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
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 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 2-month follow-up testing sessions, participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at 2-months follow-up testing sessions.
Civilians 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 session 10 and one time following treatment competition (i.e., 2-months). For participants who complete the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment session 10 and one time following competition of the second treatment (i.e., 2-months).
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 14 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
Device: Active Transcranial direct current stimulation · Device: Sham Transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
Device: Active Transcranial direct current stimulation · Device: Sham Transcranial direct current stimulation
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 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.
The Controlled Oral Word Association Test
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test, including both letter and category fluency. Metric: Number of Correct Items Generated
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Boston Naming Test
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Rey Auditory Verbal Learning Test and alternative lists
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Delis Kaplan Color Word Interference Test
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Trail Making Test (Parts A & B)
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Digit Span Forward & Backward
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward \& Backward. Metric: Memory Span
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Rey-Osterrieth Complex Figure Test
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score 0 to 36, the higher the better
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Digit Symbol Substitution Test
Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Task-based electroencephalography (EEG) markers during a Go-NoGo task
Evaluation of treatment differences (active versus sham) in EEG change on a Go-NoGo task with different levels of perceptual/semantic complexity. Metric: event-related potentials and time frequency changes.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task
Evaluation of treatment differences (active versus sham) in EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Plan to share: Undecided — Will share data upon request.
Ran from Dec 2024 to primary completion in Nov 2025, 11 months.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's 11 months is below that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas at Dallas