Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity
NCT05669508 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-04-11
Summary
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.
Conditions
- Spinal Cord Injuries
- Spinal Cord Diseases
Interventions
- DEVICE
-
RISES-T System
Non-invasive closed-loop electrical stimulation of the spinal cord through the skin
- OTHER
-
Occupational/Physical Therapy
Exercise therapy to improve function of upper and/or lower limbs
Sponsors & Collaborators
-
Kessler Foundation
collaborator OTHER -
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Mijail D Serruya, MD, PhD · Thomas Jefferson University
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-10
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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