An interventional study of Active Transcranial direct current stimulation and Sham Transcranial direct current stimulation in Traumatic Brain Injury, Word Finding Difficulty and Acquired Brain Injury, sponsored by The University of Texas at Dallas. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
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). Magnetic resonance imaging of the brain will be obtained only at the baseline assessment.
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).
This study was funded by NIH/NIDCD under grant number [1K99DC020185]. Federal funding concluded on 11/30/2024.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 5 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.
Inclusion Criteria: Participants are to be between the ages of 18-85, are non-military personnel and not veterans, and have had a traumatic brain injury (more than a year ago prior to study participation) that has led to a complaint of word finding difficulty since the brain injury, confirmed to represent 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:
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.
Also known as: tDCS, 1 milliamp tDCS, High definition tDCS, High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
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. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Category Fluency
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.
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 - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Semantic Object Retrieval Test
Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance.
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, Naming
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
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, Reading
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
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, Inhibition
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
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, Inhibition and Switching
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance.
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, Total Learning
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance.
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, Delayed Recall
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Trail Making Test - Part A
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Trail Making Test - Part B
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Digit Span Forward
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a forward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Digit Span Backward
Evaluation of treatment differences (active versus sham) in change in Digit Span Backward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a backward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Rey-Osterrieth Complex Figure Test - Delayed Recall
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score. Total Range 0 (minimum) - 36 (maximum). This is a summed score of the number and accuracy of complex figure features captured. Larger numbers indicate better performance.
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. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance.
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
| Milestone | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
| Milestone | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
| Milestone | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
| Milestone | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation |
|---|---|---|
| Started | 3 | 2 |
| Completed | 2 | 2 |
| Not completed | 1 | 0 |
| Milestone | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 30.67 ± 7.23 | 30.5 ± 0.71 |
| Immediate post completion of phase 1 intervention | 33.33 ± 5.69 | 35 ± 0 |
| 8 weeks post completion of phase 1 intervention | 34.67 ± 7.51 | 39.5 ± 7.78 |
| Immediate post completion of phase 2 intervention | 31 ± 9.9 | 48.5 ± 3.54 |
| 8 weeks post completion of phase 2 intervention | 33.5 ± 4.95 | 43.5 ± 4.95 |
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 18 ± 1.73 | 17 ± 0 |
| Immediate post completion of phase 1 intervention | 17.67 ± 6.35 | 24.5 ± 0.71 |
| 8 weeks post completion of phase 1 intervention | 20 ± 2.65 | 22.5 ± 0.71 |
| Immediate post completion of phase 2 intervention | 11 ± 1.41 | 27.5 ± 3.54 |
| 8 weeks post completion of phase 2 intervention | 17.5 ± 2.12 | 20.5 ± 0.71 |
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 26.67 ± 2.52 | 28 ± 0 |
| Immediate post completion of phase 1 intervention | 27 ± 1 | 29.5 ± 0.71 |
| 8 weeks post completion of phase 1 intervention | 27.33 ± 1.53 | 28.5 ± 2.12 |
| Immediate post completion of phase 2 intervention | 27 ± 1.41 | 30 ± NA |
| 8 weeks post completion of phase 2 intervention | 28 ± 2.83 | 30 ± 0 |
Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 30.33 ± 1.53 | 30.5 ± 2.12 |
| Immediate post completion of phase 1 intervention | 31.33 ± 1.15 | 31.5 ± 0.71 |
| 8 weeks post completion of phase 1 intervention | 30.67 ± 1.15 | 31 ± 1.41 |
| Immediate post completion of phase 2 intervention | 30 ± 1.41 | 31 ± NA |
| 8 weeks post completion of phase 2 intervention | 32 ± 0 | 31.5 ± 0.71 |
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
| Time - seconds | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 35.66666667 ± 5.131601439 | 41 ± 7.071067812 |
| Immediate post completion of phase 1 intervention | 32.66666667 ± 2.516611478 | 31 ± 8.485281374 |
| 8 weeks post completion of phase 1 intervention | 31.66666667 ± 4.509249753 | 34.5 ± 7.778174593 |
| Immediate post completion of phase 2 intervention | 34.5 ± 3.535533906 | 32 ± NA |
| 8 weeks post completion of phase 2 intervention | 29 ± 5.656854249 | 34.5 ± 3.535533906 |
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
| Time - seconds | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 26 ± 6.244997998 | 27.5 ± 12.02081528 |
| Immediate post completion of phase 1 intervention | 24 ± 7 | 24 ± 4.242640687 |
| 8 weeks post completion of phase 1 intervention | 25.66666667 ± 6.658328118 | 25.5 ± 7.778174593 |
| Immediate post completion of phase 2 intervention | 31.5 ± 3.535533906 | 27 ± NA |
| 8 weeks post completion of phase 2 intervention | 24.5 ± 0.707106781 | 27 ± 4.242640687 |
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
| Time - seconds | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 37.66666667 ± 14.36430762 | 41.5 ± 7.778174593 |
| Immediate post completion of phase 1 intervention | 27.66666667 ± 11.93035345 | 26.5 ± 13.43502884 |
| 8 weeks post completion of phase 1 intervention | 28 ± 19.28730152 | 27 ± 5.656854249 |
| Immediate post completion of phase 2 intervention | 30.5 ± 14.8492424 | 29 ± NA |
| 8 weeks post completion of phase 2 intervention | 34.5 ± 26.1629509 | 26.5 ± 9.192388155 |
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.
| Time - seconds | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 68.66666667 ± 21.57158625 | 101 ± 9.899494937 |
| Immediate post completion of phase 1 intervention | 63.66666667 ± 3.511884584 | 52.5 ± 16.26345597 |
| 8 weeks post completion of phase 1 intervention | 57.66666667 ± 21.22105872 | 63.5 ± 7.778174593 |
| Immediate post completion of phase 2 intervention | 61.5 ± 10.60660172 | 62 ± NA |
| 8 weeks post completion of phase 2 intervention | 58 ± 15.55634919 | 71.5 ± 7.778174593 |
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a forward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
| Units on Z scale | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 0.933333333 ± 1.078579312 | 0.4 ± 0.707106781 |
| Immediate post completion of phase 1 intervention | 0.3 ± 0.556776436 | -0.085 ± 0.021213203 |
| 8 weeks post completion of phase 1 intervention | -0.34 ± 0.819023809 | -0.1 ± 0 |
| Immediate post completion of phase 2 intervention | 0.05 ± 0.494974747 | -1.05 ± NA |
| 8 weeks post completion of phase 2 intervention | -0.85 ± 0.777817459 | -0.575 ± 0.671751442 |
Evaluation of treatment differences (active versus sham) in change in Digit Span Backward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a backward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.
| Units on Z scale | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 0.2 ± 1.252996409 | 0.7 ± 1.272792206 |
| Immediate post completion of phase 1 intervention | -0.933333333 ± 0.56862407 | 1.525 ± 0.035355339 |
| 8 weeks post completion of phase 1 intervention | 0.44 ± 0.991362699 | 0.25 ± 0.636396103 |
| Immediate post completion of phase 2 intervention | 0.81 ± 1.965756852 | -0.19 ± NA |
| 8 weeks post completion of phase 2 intervention | 0.385 ± 2.566797616 | 0.68 ± 0.028284271 |
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.
| Time - seconds | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 57 ± 5 | 71.5 ± 9.192388155 |
| Immediate post completion of phase 1 intervention | 46 ± 2.645751311 | 64 ± 9.899494937 |
| 8 weeks post completion of phase 1 intervention | 53 ± 3.464101615 | 58.5 ± 9.192388155 |
| Immediate post completion of phase 2 intervention | 48 ± 5.656854249 | 66 ± NA |
| 8 weeks post completion of phase 2 intervention | 46.5 ± 0.707106781 | 59.5 ± 2.121320344 |
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance.
| Time - seconds | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 71.33333333 ± 19.85782801 | 75 ± 16.97056275 |
| Immediate post completion of phase 1 intervention | 72 ± 29.13760457 | 58 ± 8.485281374 |
| 8 weeks post completion of phase 1 intervention | 75.33333333 ± 24.19366308 | 56.5 ± 6.363961031 |
| Immediate post completion of phase 2 intervention | 61.5 ± 3.535533906 | 53 ± NA |
| 8 weeks post completion of phase 2 intervention | 70 ± 9.899494937 | 52 ± 0 |
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 40.66666667 ± 15.14375559 | 48.5 ± 3.535533906 |
| Immediate post completion of phase 1 intervention | 39.33333333 ± 11.8462371 | 57 ± 7.071067812 |
| 8 weeks post completion of phase 1 intervention | 43.66666667 ± 11.59022577 | 58 ± 4.242640687 |
| Immediate post completion of phase 2 intervention | 40.5 ± 17.67766953 | 73 ± NA |
| 8 weeks post completion of phase 2 intervention | 38.5 ± 3.535533906 | 63 ± 7.071067812 |
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 7.333333333 ± 5.033222957 | 9.5 ± 0.707106781 |
| Immediate post completion of phase 1 intervention | 6 ± 4.582575695 | 12 ± 1.414213562 |
| 8 weeks post completion of phase 1 intervention | 8.666666667 ± 4.509249753 | 13.5 ± 2.121320344 |
| Immediate post completion of phase 2 intervention | 7.5 ± 6.363961031 | 15 ± NA |
| 8 weeks post completion of phase 2 intervention | 7 ± 1.414213562 | 11.5 ± 3.535533906 |
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score. Total Range 0 (minimum) - 36 (maximum). This is a summed score of the number and accuracy of complex figure features captured. Larger numbers indicate better performance.
| Score on a scale | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 15.16666667 ± 0.577350269 | 25.5 ± 2.121320344 |
| Immediate post completion of phase 1 intervention | 18.5 ± 3.905124838 | 28 ± 9.899494937 |
| 8 weeks post completion of phase 1 intervention | 18 ± 5.408326913 | 32.5 ± 0.707106781 |
| Immediate post completion of phase 2 intervention | 14 ± 9.899494937 | 31 ± NA |
| 8 weeks post completion of phase 2 intervention | 24 ± 11.3137085 | 25.45 ± 3.606244584 |
Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance.
| Total items | Active to Sham | Sham to Active |
|---|---|---|
| Baseline | 45 ± 5.196152423 | 45.5 ± 14.8492424 |
| Immediate post completion of phase 1 intervention | 45.33333333 ± 2.516611478 | 58 ± 11.3137085 |
| 8 weeks post completion of phase 1 intervention | 47.66666667 ± 1.527525232 | 58.5 ± 23.33452378 |
| Immediate post completion of phase 2 intervention | 50 ± 4.242640687 | 53 ± NA |
| 8 weeks post completion of phase 2 intervention | 48 ± 4.242640687 | 62.5 ± 9.192388155 |
Collected over from enrollment until end of follow-up, up to 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active to Sham Transcranial Direct Current Stimulation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Sham to Active Transcranial Direct Current Stimulation | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Geometric mean | 47.7 ± 24.6 | 50 ± 15.6 | 48.6 ± 19.1 |
| Sex: Female, Male(Participants) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 2 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
| The Controlled Oral Word Association Test(items) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Mean | 30.67 ± 7.23 | 30.5 ± 0.71 | 30.6 ± 5.13 |
| Category Fluency(Total items) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Mean | 18 ± 1.73 | 17 ± 0 | 17.6 ± 1.34 |
| The Boston Naming Test(Total items) | Active to Sham Transcranial Direct Current Stimulation | Sham to Active Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Mean | 26.67 ± 2.52 | 28 ± 0 | 27.2 ± 1.93 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Will share data upon request.
Ran from Jan 2023 to primary completion in Nov 2024, 22 months.
Results were first posted in Feb 2026, 1 year 2 months after primary completion.
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 22 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 Jan 2026. You cannot join it, but the record below documents what was studied.
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