tDCS and Cognitive Training for Traumatic Brain Injury

Overseen By Kelvin O Lim, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Minneapolis Veterans Affairs Medical Center

Disqualifiers: Neurological disorder, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 week

33 Participants Needed

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham tDCS paired with cognitive training tasks once a day for five days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 1, 2, and 3 months

3 months

3 visits (in-person)

Treatment Details

Interventions

• Active Transcranial Direct Current Stimulation (tDCS)
• Combined tDCS and Cognitive Training
• Sham Transcranial Direct Current Stimulation (tDCS)

Trial Overview 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.

Participant Groups

Group I: Active tDCS Experimental Treatment 1 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 tDCS Placebo Group 1 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:

• Treatment-resistant depression
• Chronic pain
• Cognitive enhancement
• Research purposes including suicide prevention

Approved in European Union as Transcranial Direct Current Stimulation for:

• Treatment-resistant depression
• Chronic pain
• Cognitive enhancement
• Research purposes including neurological and psychiatric conditions

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center

Lead Sponsor

Trials

77

Recruited

355,000+

The Defense and Veterans Brain Injury Center

Collaborator

Trials

21

Recruited

2,900+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

Minnesota Office of Higher Education

Collaborator

Trials

6

Recruited

280+