Clinical trial NCT05669508: Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity
Official title: The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: Spinal Cord Injuries
Spinal Electrical Stimulation
Transcutaneous Spinal Stimulation
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Kessler Foundation
First posted: 2023-01-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

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

Primary outcomes:
measure: Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
timeFrame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Secondary outcomes:
measure: Change from Baseline - Spinal Cord Independence Measures (SCIM)
timeFrame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
measure: Change from Baseline - Canadian Occupational Performance Measure (COPM)
timeFrame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
measure: Change from Baseline - Capabilities of Upper Extremity (CUE-T)
timeFrame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
measure: Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: Repeated measurements once every 6 weeks throughout the study, an average of 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Mijail D Serruya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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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.
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.