Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (HDtDCS-TBI)

September 17, 2025 updated by: John Hart, Jr., The University of Texas at Dallas

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transcranial direct current stimulation
20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions
Device: 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.
Other Names:
  • tDCS
  • 1 milliamp tDCS
  • High definition tDCS
  • High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
Sham Comparator: Sham transcranial direct current stimulation
20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions
Device: sham tDCS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas at Dallas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Hart, MD, University of Texas at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTD-TDCSTBI-21-15
  • CDMRP-PT190081 (Other Identifier: CDMRP)
  • W81XWH-20-1-0846 (Other Grant/Funding Number: DOD-CDMRP-USAMRDC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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