tDCS for Traumatic Brain Injury

Overseen by Tasha M Nienow, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Minneapolis Veterans Affairs Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary aim of this study is to assess the magnitude of transcranial direct current stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic brain injury. This study will also attempt to identify biomarkers associated with treatment response. Last, acceptability and tolerability of procedures will be assessed. To accomplish these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will be conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation offered concurrent with working memory training. Neural efficiency will be measured with electroencephalogram (EEG) pre and post-intervention.

Research Team

Tasha M Nienow, PhD

Principal Investigator

Minneapolis Veteran Affairs Health Care System

Eligibility Criteria

This trial is for veterans aged 18-65 who have had a mild traumatic brain injury over a year ago and are enrolled at the Minneapolis VA Health Care System. It's not for those with psychotic disorders, recent substance use issues, severe depression, other cognitive impairments, or medical conditions that don't allow TDCS.

Inclusion Criteria

You had a minor brain injury over a year ago that still affects you.

Veterans enrolled at the Minneapolis Veterans Affairs (VA) Health Care System

Age of 18 and 65

Exclusion Criteria

You have a mental disorder that causes you to lose touch with reality or experience hallucinations.

You have been using drugs or alcohol in small amounts over the past month.

You have had a serious problem with drug or alcohol abuse in the past six months.

Treatment Details

Interventions

• Anodal Transcranial Direct Current Stimulation (Behavioural Intervention)
• Sham stimulation (Procedure)

Trial Overview The study tests if transcranial direct current stimulation (TDCS) can improve cognition in patients with mild traumatic brain injury. Participants will be randomly assigned to receive either real TDCS or sham stimulation alongside working memory training.

Participant Groups

Group I: Transcranial Direct Current Stimulation Experimental Treatment 1 Intervention

Participants will receive 24 sessions (3 times a week) of anodal transcranial direct current stimulation concurrent with working memory training. Stimulation will be administered at 2 milliamps (mA) for 20 minutes over the left dorsal lateral prefrontal cortex.

Group II: Sham Placebo Group 1 Intervention

Participants will receive 24 sessions of working memory training. The experience of transcranial direct current stimulation will be simulated by administering 30 seconds of stimulation at the beginning of the session.

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center

Lead Sponsor

Trials

77

Recruited

355,000+

Minnesota Veterans Medical Research and Education Foundation

Collaborator

Trials

4

Recruited

170+

State of Minnesota

Collaborator

Trials

1

Recruited

40+