About this trial
The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.
Eligibility criteria
Qualifiers
22-70 years of age
Non-progressive cervical spinal cord injury
Minimum 12 months year post-injury.
American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
Disqualifiers
Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
Has uncontrolled cardiopulmonary disease or cardiac symptoms.
Requires ventilator support.
Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
Trial design
Treatments tested in this trial
- Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
Treatment groups
Sponsors and collaborators
University of Miami
Lead sponsor
ONWARD Medical, Inc.
Collaborator
United States Department of Defense
Collaborator