High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury

(NAVIGATE-TBI Trial)

Recruiting in Palo Alto (17 mi)

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

Trial Summary

What is the purpose of this trial?

Aim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as shown by reliable changes in the activity of the cognitive control network (CCN) and sensory system network (SSN) following stimulation; Aim 2: this intervention will result in long-term improvements in measures of executive function, depression/anxiety, and quality of life.

Research Team

Eligibility Criteria

Inclusion Criteria

are US Veteran or Active Duty Military personnel aged 18-59

have suffered a mild TBI (alteration in neurological functioning < 24 hours, loss of consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA));

were injured between 3 months and 15 years ago;

Treatment Details

Interventions

• High-definition transcranial direct current stimulation (HD-tDCS) (Non-invasive Brain Stimulation)

Participant Groups

Group I: Active Stimulation Active Control 1 Intervention

Active HD-tDCS will be delivered while subjects perform sensory training tasks.

Group II: Imaging Only Active Control 1 Intervention

40 subjects will undergo initial testing only as a healthy control group.

Group III: Sham Stimulation Placebo Group 1 Intervention

Sham HD-tDCS will be delivered while subjects perform sensory training tasks.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of New Mexico Health Sciences Center Albuquerque, NM

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Patients Recruited

3,526,000+

Biomedical Research Institute of New Mexico

Collaborator

Trials

11

Patients Recruited

2,300+

New Jersey Institute of Technology

Collaborator

Trials

11

Patients Recruited

1,100+

University of Miami

Collaborator

Trials

976

Patients Recruited

423,000+

The Mind Research Network

Collaborator

Trials

27

Patients Recruited

2,300+

The City College of New York

Collaborator

Trials

32

Patients Recruited

6,700+