Recruiting

High Definition tDCS

Sponsor:

The University of Texas at Dallas

Code:

NCT04869059

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial direct current stimulation

sham tDCS

Study Details

Brief 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 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.

Conditions

Traumatic Brain Injury

Study ID

NCT04869059

Start date

Aug 1, 2021

Status verified date

Sep, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial direct current stimulation

20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions

sham comparator: Sham transcranial direct current stimulation

20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions

Interventions

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 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.

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Ashna Adhikari

972-883-3161neurolab.memory@utdallas.edu

Jill Ritter, BS

972-883-3161neurolab.memory@utdallas.edu

Locations

The University of Texas at Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Ashna Adhikari

972-883-3161neurolab.memory@utdallas.edu

Tyler Vintila

972-883-3161neurolab.memory@utdallas.edu

More Information

Sponsor

The University of Texas at Dallas

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

  • Traumatic brain injury
  • transcranial direct current stimulation
  • electroencephalography
  • cognition
  • veteran traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas at Dallas on 2025-09-23.