Phase
Condition
Spinal Cord Injuries
Treatment
Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
Clinical Study ID
Ages 22-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Able to take part in upper extremity therapy procedures.
GRASSP-Prehension score ≥10.
MAS Score ≥3 but <6 in at least one arm.
Can commit to the time required for the study.
Stable medication profile for at least 4 weeks prior to enrollment.
Able to reduce Baclofen dose to 30 mg or less daily.
Capable of providing informed consent.
Exclusion
Exclusion Criteria:
Has any unstable or significant medical condition that is likely to interfere withstudy procedures like severe neuropathic pain, depression, mood disorders, or othercognitive disorders.
Has uncontrolled cardiopulmonary disease or cardiac symptoms.
Requires ventilator support.
Has been diagnosed with autonomic dysreflexia that is severe, unstable, anduncontrolled.
Has an autoimmune etiology of spinal cord dysfunction/injury
Previously diagnosed as having transverse myelitis
History of additional neurologic diseases such as stroke, multiple sclerosis,traumatic brain injury, epilepsy or history of seizures.
Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
Uncontrolled spasms, which have been unstable over the past three months prior toenrollment and are not expected to change.
Received Botulinum toxin injections in their upper extremity, neck, or hand withinsix months prior to enrollment.
Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressuresore, or urinary tract infection at the time of enrollment.
Breakdown in skin area that will come into contact with electrodes.
Presence of syringomyelia as determined by an MRI.
Currently undergoing treatment for cancer or has been in remission for less than 2years.
Received stem cell treatment within the past two years prior to enrollment.
Has any active implanted medical device.
Concurrent participation in another drug or device trial that may interfere withthis study.
In the opinion of the investigators, the study is not safe or appropriate for theparticipant.
Persons who are unable to consent, pregnant women, and prisoners.
Study Design
Connect with a study center
University of Miami - Christine E. Lynn Rehabilitation Center
Miami, Florida 33136
United StatesActive - Recruiting
University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
Miami, Florida 33136
United StatesActive - Recruiting
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