Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury

Overseen by William Shuttleworth, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of New Mexico

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 5 years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (active or sham) combined with cognitive training. On day 10 NP testing will be obtained again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of life, depression, and post concussive symptoms will be assessed.

Research Team

William Shuttleworth, PhD

Principal Investigator

UNM Center for Brain Recovery and Repair

Eligibility Criteria

Inclusion Criteria

aged 18-55

TBI with + loss of consciousness (LOC) less than 24 hours

injured between 3 months and 5 years ago

Treatment Details

Interventions

• Anodal tDCS (Device)
• Cognitive training (Behavioral Intervention)

Participant Groups

Group I: Active anodal tDCS + cognitive training Experimental Treatment 2 Interventions

In this arm, patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.

Group II: Placebo anodal tDCS + cognitive training Placebo Group 1 Intervention

In this arm, patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.

Anodal tDCS is already approved in Canada for the following indications:

Approved in Canada as tDCS for:

• Depression
• Chronic pain
• Stroke rehabilitation
• Research purposes including stuttering

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Lisa Kuuttila

University of New Mexico

Chief Executive Officer since 2013

PhD in Pharmaceutical Sciences

David L. Perkins

University of New Mexico

Chief Medical Officer since 2015

MD, PhD

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University