Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity (RISES-T)

August 22, 2023 updated by: Mijail Demian Serruya, Thomas Jefferson University

The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is investigating the use of transcutaneous spinal cord stimulation, where the electrical stimulation is delivered non-invasively via surface electrodes placed on the skin along the spine. The trial will have two phases: open-loop transcutaneous spinal cord stimulation (SCS) phase (where stimulation parameters are selected and subsequently fixed for each stimulation sessions) and closed-loop transcutaneous SCS phase, (where stimulation parameters are continuously revised in real-time during each session based upon the exact movement state of the person as captured by wearable kinematic and electromyographic sensors). For both open-loop and closed-loop phases, the transcutaneous spinal cord stimulation will be incorporated into Functional Task Practice (FTP) sessions guided closely by a team of trained technicians and occupational and physical therapists.

Upon enrollment, participants will complete a baseline assessment of outcome measures validated for spinal cord injury rehabilitation. They will also undergo mapping with sensors of their movements without stimulation to simply characterize their unique "motor signature". Then they will undergo the same mapping with open-loop transcutaneous SCS applied to determine if and how stimulation at a variety of settings can modify their unique "motor signature". They will then participate in the open-loop phase - 15 open-loop SCS+FTP sessions - after which they will repeat the outcome measures (interim assessment). They will then proceed to the closed-loop phase - 15 closed-loop SCS+FTP sessions - after which they will repeat the outcome measures a final time (endpoint assessment).

Study Type

Interventional

Enrollment (Estimated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a non-progressive or central cord spinal cord injury from C2-T10 inclusive
  • Has American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
  • Can participate in physical and occupational therapy rehabilitation programs
  • Is at minimum 12 months post- spinal cord injury
  • Can provide informed consent
  • Has adequate caregiver support to facilitate participation in study

Exclusion Criteria:

  • Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by the Investigator)
  • Has diffuse lower motor neuron injury rendering majority of muscles not excitable
  • Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders
  • Has autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation.
  • Requires ventilator support
  • Has an autoimmune etiology of spinal cord dysfunction/injury
  • Has spasms that limit the ability to participate in the study training (as determined by the Investigator)
  • Has skin breakdown in area(s) that will come into contact with electrodes
  • Has any active implanted medical device
  • Is pregnant, planning to become pregnant or currently breastfeeding
  • Has concurrent participation in another drug or device trial that may interfere with this study
  • Has other traumatic injuries such as peripheral nerve injuries, severe musculoskeletal injuries (e.g., shattered pelvis, long bone fractures), that prevent evaluation of response to or participation in rehabilitation.
  • Is deemed ineligible because the investigators believe the study would not be safe or appropriate for the individual

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.
Device: RISES-T System
Non-invasive closed-loop electrical stimulation of the spinal cord through the skin
Other Names:
  • Transcutaneous spinal stimulation
Other: Occupational/Physical Therapy
Exercise therapy to improve function of upper and/or lower limbs
Other Names:
  • Functional Task Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time Frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Standard neurological assessment for determining level and severity of impairment after spinal cord injury. It includes a sensory exam (dermatological light touch and pin prick) and motor exam (manual muscle strength testing).
Repeated measurements once every 6 weeks throughout the study, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline - Spinal Cord Independence Measures (SCIM)
Time Frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Validated measure that evaluates self-care (feeding, grooming, bathing, dressing), respiration and sphincter management, and mobility abilities (transfers and indoor/outdoor).
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from Baseline - Canadian Occupational Performance Measure (COPM)
Time Frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Participant-centered instrument that measures changes in how participants perceive their own functional performance and challenges in daily living; participants identify goals of most importance to them in areas of functional tasks and occupational performance including self-care, leisure, and productivity.
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from Baseline - Capabilities of Upper Extremity (CUE-T)
Time Frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Validated objective measure of upper extremity functional capabilities in persons with SCI; evaluates the ability to perform various actions (reach up, pull up, picking up a pencil with tips of fingers).
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)
Time Frame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Validated performance measures to assess walking speed and amount of physical assistance needed/assistive devices required for walking respectively.
Repeated measurements once every 6 weeks throughout the study, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Kessler Foundation

Investigators

  • Principal Investigator: Mijail D Serruya, MD, PhD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rises-T 22D.126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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