Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity

NCT05669508 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Rises-T 22D.126
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

Spinal Cord Injuries; Spinal Electrical Stimulation; Transcutaneous Spinal Stimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  Repeated measurements once every 6 weeks throughout the study, an average of 3 months

Secondary Outcomes (4)

• Change from Baseline - Spinal Cord Independence Measures (SCIM)

  Repeated measurements once every 6 weeks throughout the study, an average of 3 months

• Change from Baseline - Canadian Occupational Performance Measure (COPM)

  Repeated measurements once every 6 weeks throughout the study, an average of 3 months

• Change from Baseline - Capabilities of Upper Extremity (CUE-T)

  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)

  Repeated measurements once every 6 weeks throughout the study, an average of 3 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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; Other: Occupational/Physical Therapy

Interventions

RISES-T System DEVICE

Non-invasive closed-loop electrical stimulation of the spinal cord through the skin

Also known as: Transcutaneous spinal stimulation

Treatment Arm

Occupational/Physical Therapy OTHER

Exercise therapy to improve function of upper and/or lower limbs

Also known as: Functional Task Practice

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Kessler Foundation: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (9)

• 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.

  PMID: 26205686 BACKGROUND

• 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.

  PMID: 36212800 BACKGROUND

• 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.

  PMID: 34362062 BACKGROUND

• 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.

  PMID: 33192348 BACKGROUND

• 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.

  PMID: 35160091 BACKGROUND

• 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.

  PMID: 30190556 BACKGROUND

• 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.

  PMID: 26779815 BACKGROUND

• 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.

  PMID: 29877852 BACKGROUND

• 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.

  PMID: 30382197 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mijail D Serruya, MD, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: January 3, 2023
• Study Start: February 10, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)