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

N/A

Waitlist Available

Led By Mijail D Serruya, MD, PhD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up repeated measurements once every 6 weeks throughout the study, an average of 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how electrical stimulation of the spinal cord can help people with paralysis due to SCI improve their strength and function in their arms, legs, hands, and feet.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the electrode sites on the back during electrical stimulation sessions. There might also be a risk of muscle fatigue from increased activity during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ repeated measurements once every 6 weeks throughout the study, an average of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~repeated measurements once every 6 weeks throughout the study, an average of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated measurements once every 6 weeks throughout the study, an average of 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

Secondary study objectives

Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)

Change from Baseline - Canadian Occupational Performance Measure (COPM)

Change from Baseline - Capabilities of Upper Extremity (CUE-T)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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