Non-Invasive Electrical and Magnetic Neuromodulation in Persons With Chronic Spinal

NCT05994846 | Suspended DMC FDA Device

• 1 other identifier: Rises-T 2.0 iRISID-2023-2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to (1) determine the effects of neuromodulation techniques on mobility in persons with chronic SCI, as measured by subjective and objective measures, and (2) to determine the optimal combination of techniques that modify mobility and movement in an individual. The neuromodulation techniques explored will be methods of electromagnetic stimulation - that is, electrical stimulation and magnetic stimulation.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

Spinal Cord Injuries; Spinal Electrical Stimulation; Transcutaneous Spinal Stimulation; Transcutaneous Magnetic Simulation; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Spinal Cord Injury-Motor Index (SCI MovIN)

  evaluates movement, and recovery of neurotypical movement, within a functional context that accounts for compensations and disallows substitutions

  Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks

• Modified Ashworth Scale (MAS)

  measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone

  Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks

• Manual Muscle Testing (MMT)

  standardized set of assessments that measure muscle strength and function

  Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks

Secondary Outcomes (5)

• Capabilities of Upper Extremity Test (CUE-T)

  Once at 2 weeks after consent, and once within 9-24 weeks after consent

• PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI)

  Once at 2 weeks after consent, and once within 9-24 weeks after consent

• Walking Index for SCI (WISCI-II)

  Once at 2 weeks after consent, and once within 9-24 weeks after consent

• Numeric Pain Rating Scale (NPRS)

  Once at 2 weeks after consent, and once within 9-24 weeks after consent

• Patient Global Impression of Change (PGIC) Questionnaires (bowel program, bladder function, dysreflexia, pain, sensation)

  Once at 2 weeks after consent, and once within 9-24 weeks after consent

Study Arms (1)

Experimental Treatment Arm

EXPERIMENTAL

Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing repetitive task practice

Device: RISES-T System

Interventions

RISES-T System DEVICE

The RISES-T system is a hardware and software platform that has been designed and developed to help people living with movement impairment due to Spinal Cord Injury (SCI) to improve and/or restore mobility. The hardware consists of a functional electrical stimulation device that delivers stimulation to the skin through surface electrodes; a series of wearable sensors that collect kinematic (IMU) data and muscle activity (EMG) data, and RISES Software, which incorporates algorithms that utilizes the streaming IMU and EMG sensor data to inform the electrical stimulation parameters and enables real-time visualization of the sensor data and stimulation parameters via Graphical User Interface (GUI).

Also known as: Trancutaneous spinal stimulation

Experimental Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by investigators)
• 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 (e.g., cochlear implant, pacemaker, neurostimulator or medication infusion 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 not a candidate for other reason determined by the investigators

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (10)

• 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

• Najib U, Bashir S, Edwards D, Rotenberg A, Pascual-Leone A. Transcranial brain stimulation: clinical applications and future directions. Neurosurg Clin N Am. 2011 Apr;22(2):233-51, ix. doi: 10.1016/j.nec.2011.01.002.

  PMID: 21435574 BACKGROUND

• Pascual-Leone A, Freitas C, Oberman L, Horvath JC, Halko M, Eldaief M, Bashir S, Vernet M, Shafi M, Westover B, Vahabzadeh-Hagh AM, Rotenberg A. Characterizing brain cortical plasticity and network dynamics across the age-span in health and disease with TMS-EEG and TMS-fMRI. Brain Topogr. 2011 Oct;24(3-4):302-15. doi: 10.1007/s10548-011-0196-8. Epub 2011 Aug 14.

  PMID: 21842407 BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Prospective, unblinded, feasibility study where participants will serve as their own controls.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 16, 2023
• Study Start: June 23, 2023
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)