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Behavioural Intervention

Transcranial Direct Current Stimulation for Mild Traumatic Brain Injury (HDtDCS-TBI Trial)

N/A
Recruiting
Led By John Hart, MD
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have had a traumatic brain injury that has led to a verbal retrieval deficit based on neuropsychological testing criteria
Participants must be between the ages of 18-75
Must not have
Cranial implants or skull defects that affect tDCS administration
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measures will be assessed as change over a period of 17 weeks: change from baseline to 3-month post-treatment

Summary

This trial is testing whether stimulating the brain with low levels of electricity can help improve verbal memory in military veterans with a history of concussion.

Who is the study for?
This trial is for US military veterans aged 18-75 with mild to moderate traumatic brain injury that has affected their verbal skills. They must be fluent in English and have no severe neurological disorders, drug abuse history, or conditions affecting the brain's blood vessels. Participants taking certain medications or with cranial implants cannot join.
What is being tested?
The study tests if a low-level electric brain stimulation technique called transcranial Direct Current Stimulation (tDCS) can improve memory-related verbal skills in participants with traumatic brain injuries. It compares real tDCS to sham (fake) treatment using neuropsychological assessments and EEG measures.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue, nausea. More serious risks are rare but could involve seizures or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have difficulty finding words due to a brain injury.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have implants or defects in my skull that could interfere with brain stimulation treatments.
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I am not taking any medication that could affect tDCS treatment.
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I have a history of serious brain-related health issues or substance abuse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measures will be assessed as change over a period of 17 weeks: change from baseline to 3-month post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measures will be assessed as change over a period of 17 weeks: change from baseline to 3-month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment group differences in change from Baseline to 2-months Post-Treatment in Category Fluency
Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
+7 more
Secondary study objectives
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial direct current stimulationExperimental Treatment1 Intervention
20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions
Group II: Sham transcranial direct current stimulationPlacebo Group1 Intervention
20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial direct current stimulation
2012
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor
64 Previous Clinical Trials
106,764 Total Patients Enrolled
John Hart, MDPrincipal InvestigatorUniversity of Texas at Dallas
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Transcranial direct current stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04869059 — N/A
Traumatic Brain Injury Research Study Groups: Transcranial direct current stimulation, Sham transcranial direct current stimulation
Traumatic Brain Injury Clinical Trial 2023: Transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT04869059 — N/A
Transcranial direct current stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04869059 — N/A
~15 spots leftby Aug 2025
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