Spinal Stimulation for Traumatic Brain Injury
(DOD SS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Kessler Foundation

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.

Eligibility Criteria

This trial is for individuals with hemiplegic traumatic brain injury (TBI) who have difficulty moving one side of their body. Participants should be able to perform walking exercises with or without assistance.

Inclusion Criteria

Have weakness on at least one side of the body

I had a non-penetrating brain injury over 2 years ago.

I can handle and respond well to surface stimulation.

+10 more

Exclusion Criteria

I have had ringing in my ears or severe hearing issues.

Hospitalization for heart-related issues within 3 months of study enrollment

Physical therapy for walking

+20 more

Participant Groups

The study is testing the effectiveness of transcutaneous spinal cord stimulation during walking exercises versus doing the same exercises without such stimulation in improving mobility for TBI patients.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TBI with StimExperimental Treatment1 Intervention

Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord to provide stimulation during walking.

Group II: TBI with ShamPlacebo Group1 Intervention