Status:
SUSPENDED
Non-Invasive Electrical and Magnetic Neuromodulation in Persons With Chronic Spinal
Lead Sponsor:
Thomas Jefferson University
Conditions:
Spinal Cord Injuries
Spinal Cord Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 determ...
Detailed Description
The study is designed in two Parts. Part 1 of the study will collect information about the participant's baseline mobility and muscular activation potential. The information collected in these session...
Eligibility Criteria
Inclusion
- 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
- \-
Exclusion
- 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
- \-
Key Trial Info
Start Date :
June 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05994846
Start Date
June 23 2023
End Date
June 23 2026
Last Update
September 9 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107