Wearable Electrical Stimulation for Spinal Cord Injury
(RISES-T Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMijail D Serruya, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.

Eligibility Criteria

This trial is for individuals with non-progressive spinal cord injuries from C2-T10, at least one year post-injury, and classified as B, C, or D on the ASIA scale. Participants must be able to consent and engage in physical therapy with caregiver support. It's not suitable for those with severe cardiopulmonary disease, unexcitable muscles due to lower motor neuron injury, severe neuropathic pain or cognitive disorders, skin breakdown where electrodes are placed, active implanted devices or pregnancy.

Inclusion Criteria

It has been at least a year since my spinal cord injury.

I am able to join in physical and occupational therapy programs.

Has adequate caregiver support to facilitate participation in study

+3 more

Exclusion Criteria

Has concurrent participation in another drug or device trial that may interfere with this study

My spasms prevent me from joining in study activities.

I have heart or lung conditions that are not well-managed.

+10 more

Participant Groups

The RISES-T System is being tested alongside occupational/physical therapy to see if 'smart' electrical stimulation can improve movement in people paralyzed by spinal cord injuries. The study involves exercises paired with targeted spinal stimulation to potentially enhance arm and leg function.

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment2 Interventions

Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.