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

Launched by THOMAS JEFFERSON UNIVERSITY · Aug 9, 2023

Keywords

ClinConnect Summary

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 sessions will, in effect, assess the participant's eligibility to continue in the study and move onto Part 2.

Part 1- Assessment Sessions This part of the study designed to determine (1) which, if any, of the participant's muscles respond to stimulation and, if there are responses observed, (2) what stimulation parameters and modalities would be best suited for the participant during Part 2 of the tr...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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
• • -