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Active Transcranial Direct Current Stimulation (tDCS) for Traumatic Brain Injury

N/A
Waitlist Available
Research Sponsored by Minneapolis Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical history of impulsive behavior, including substance abuse, gambling problems, legal issues such as DUI, violent acts, aggression, history of suicidality, or ADHD as assessed by the patient's clinical provider and/or screen of medical records
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
Awards & highlights

Study Summary

This trial will study how cognitive training and electrical stimulation can reduce impulsivity in TBI patients, helping them improve outcomes and quality of life.

Who is the study for?
This trial is for adults over 18 with a traumatic brain injury (TBI) who are being treated at the Minneapolis VA Health Care System. They should be stable on medications and have a history of impulsive behavior, like substance abuse or aggression. People can't join if they're pregnant, have scalp skin issues, metal in their head, active psychosis/mania, or other major neurological disorders.Check my eligibility
What is being tested?
The study tests whether combining cognitive training with an electric current treatment to the brain called tDCS can help reduce impulsivity in TBI patients. One group receives real tDCS while another gets a sham (fake) version to compare outcomes.See study design
What are the potential side effects?
tDCS may cause discomfort at the electrode site on the scalp, headache, fatigue, nausea or itching during stimulation. It's generally considered safe but individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a past history of impulsive behavior, such as substance abuse, gambling, legal problems like DUI, violent behavior, suicidal thoughts, or ADHD. Your doctor or medical records have previously noted this.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Barratt Impulsiveness Scale (BIS)
Secondary outcome measures
Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)
Change in choice of higher risk option in the Risk Task

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).
Group II: Sham tDCSPlacebo Group1 Intervention
Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Transcranial Direct Current Stimulation (tDCS)
2020
N/A
~160

Find a Location

Who is running the clinical trial?

Minneapolis Veterans Affairs Medical CenterLead Sponsor
71 Previous Clinical Trials
14,869 Total Patients Enrolled
The Defense and Veterans Brain Injury CenterFED
19 Previous Clinical Trials
2,688 Total Patients Enrolled
Center for Veterans Research and EducationOTHER
11 Previous Clinical Trials
1,474 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025