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

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISES-T System
Occupational/Physical Therapy
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Spinal Electrical Stimulation, Transcutaneous Spinal Stimulation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline - Spinal Cord Independence Measures (SCIM)
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)
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)
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)
Validated performance measures to assess walking speed and amount of physical assistance needed/assistive devices required for walking respectively.

Full Information

First Posted
November 16, 2022
Last Updated
August 22, 2023
Sponsor
Thomas Jefferson University
Collaborators
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05669508
Brief Title
Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity
Acronym
RISES-T
Official Title
The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University
Collaborators
Kessler Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases
Keywords
Spinal Cord Injuries, Spinal Electrical Stimulation, Transcutaneous Spinal Stimulation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.
Intervention Type
Device
Intervention Name(s)
RISES-T System
Other Intervention Name(s)
Transcutaneous spinal stimulation
Intervention Description
Non-invasive closed-loop electrical stimulation of the spinal cord through the skin
Intervention Type
Other
Intervention Name(s)
Occupational/Physical Therapy
Other Intervention Name(s)
Functional Task Practice
Intervention Description
Exercise therapy to improve function of upper and/or lower limbs
Primary Outcome Measure Information:
Title
Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Description
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).
Time Frame
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Secondary Outcome Measure Information:
Title
Change from Baseline - Spinal Cord Independence Measures (SCIM)
Description
Validated measure that evaluates self-care (feeding, grooming, bathing, dressing), respiration and sphincter management, and mobility abilities (transfers and indoor/outdoor).
Time Frame
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Title
Change from Baseline - Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Title
Change from Baseline - Capabilities of Upper Extremity (CUE-T)
Description
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).
Time Frame
Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Title
Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)
Description
Validated performance measures to assess walking speed and amount of physical assistance needed/assistive devices required for walking respectively.
Time Frame
Repeated measurements once every 6 weeks throughout the study, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mijail D Serruya, MD, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26205686
Citation
Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
Results Reference
background
PubMed Identifier
36212800
Citation
Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.
Results Reference
background
PubMed Identifier
34362062
Citation
Kumru H, Rodriguez-Canon M, Edgerton VR, Garcia L, Flores A, Soriano I, Opisso E, Gerasimenko Y, Navarro X, Garcia-Alias G, Vidal J. Transcutaneous Electrical Neuromodulation of the Cervical Spinal Cord Depends Both on the Stimulation Intensity and the Degree of Voluntary Activity for Training. A Pilot Study. J Clin Med. 2021 Jul 25;10(15):3278. doi: 10.3390/jcm10153278.
Results Reference
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PubMed Identifier
33192348
Citation
Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.
Results Reference
background
PubMed Identifier
35160091
Citation
Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
Results Reference
background
PubMed Identifier
30190556
Citation
Capogrosso M, Wagner FB, Gandar J, Moraud EM, Wenger N, Milekovic T, Shkorbatova P, Pavlova N, Musienko P, Bezard E, Bloch J, Courtine G. Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. Nat Protoc. 2018 Sep;13(9):2031-2061. doi: 10.1038/s41596-018-0030-9.
Results Reference
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PubMed Identifier
26779815
Citation
Wenger N, Moraud EM, Gandar J, Musienko P, Capogrosso M, Baud L, Le Goff CG, Barraud Q, Pavlova N, Dominici N, Minev IR, Asboth L, Hirsch A, Duis S, Kreider J, Mortera A, Haverbeck O, Kraus S, Schmitz F, DiGiovanna J, van den Brand R, Bloch J, Detemple P, Lacour SP, Bezard E, Micera S, Courtine G. Spatiotemporal neuromodulation therapies engaging muscle synergies improve motor control after spinal cord injury. Nat Med. 2016 Feb;22(2):138-45. doi: 10.1038/nm.4025. Epub 2016 Jan 18.
Results Reference
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PubMed Identifier
29877852
Citation
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
Results Reference
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PubMed Identifier
30382197
Citation
Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
Results Reference
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Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity

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