tDCS and Cognitive Training for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Minneapolis Veterans Affairs Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?Behavioral changes following a traumatic brain injury (TBI) are one of the biggest challenges for patients, as well as their family members and others involved in their recovery. One of the most common behavioral changes following TBI is the emergence of impulsive behavior, which has been associated with destructive, suicidal, and aggressive behavior, and is related to poor rehabilitation program adherence. The primary objective of this study is to investigate the effect of a novel neuroplasticity based intervention that combines cognitive training and transcranial direct current stimulation (tDCS) to reduce impulsivity and to improve outcomes and quality of life for those who have suffered a TBI.

Eligibility Criteria

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.

Inclusion Criteria

Age 18 or older

Receiving services from the Minneapolis VA Health Care System

Stable on any medications for at least 1 week at the baseline visit

+2 more

Exclusion Criteria

You are currently experiencing severe mental health issues such as psychosis or mania.

You have a skin condition on your scalp that may be irritated during the study.

You are currently pregnant.

+2 more

Participant Groups

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.

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.

Active Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Transcranial Direct Current Stimulation for: