NCT04869059 Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
| NCT ID | NCT04869059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas at Dallas |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2021-08-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
John Hart, MD
PRINCIPAL INVESTIGATOR
The University of Texas at Dallas
Frequently Asked Questions
Who can join the NCT04869059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04869059 currently recruiting?
Yes, NCT04869059 is actively recruiting participants. Contact the research team at neurolab.memory@utdallas.edu for enrollment information.
Where is the NCT04869059 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04869059 clinical trial?
NCT04869059 is sponsored by The University of Texas at Dallas. The principal investigator is John Hart, MD at The University of Texas at Dallas. The trial plans to enroll 136 participants.