Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity (RISES-T)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05669508 |
|
Recruitment Status :
Recruiting
First Posted : January 3, 2023
Last Update Posted : January 3, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries Spinal Cord Diseases | Device: RISES-T System Other: Occupational/Physical Therapy | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Device Feasibility |
| Official Title: | The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation |
| Actual Study Start Date : | February 10, 2022 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | December 31, 2026 |
| 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 Name: Transcutaneous spinal stimulation Other: Occupational/Physical Therapy Exercise therapy to improve function of upper and/or lower limbs
Other Name: Functional Task Practice |
- 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).
- 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).
- 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.
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05669508
| Contact: Erica Jones, BA | 215-503-4042 | CenterNR@jefferson.edu |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Erica Jones, BA 215-503-4042 CenterNR@jefferson.edu | |
| Principal Investigator: | Mijail D Serruya, MD, PhD | Thomas Jefferson University |
| Responsible Party: | Mijail Demian Serruya, Assistant Professor, Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT05669508 |
| Other Study ID Numbers: |
Rises-T 22D.126 |
| First Posted: | January 3, 2023 Key Record Dates |
| Last Update Posted: | January 3, 2023 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
|
Spinal Cord Injuries Spinal Electrical Stimulation Transcutaneous Spinal Stimulation |
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |