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tDCS and Cognitive Training 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

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

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Barratt Impulsiveness Scale (BIS)

Secondary study objectives

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

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