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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669508 on ClinicalTrials.gov