Status:
RECRUITING
Task Practice and Spinal Cord Stimulation
Lead Sponsor:
University of Miami
Collaborating Sponsors:
ONWARD Medical, Inc.
United States Department of Defense
Conditions:
Spinal Cord Injury Cervical
Spastic
Eligibility:
All Genders
22-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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 to enrollment and are not expected to change.
- Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
- Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, 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 2 years.
- 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 with this study.
- In the opinion of the investigators, the study is not safe or appropriate for the participant.
- Persons who are unable to consent, pregnant women, and prisoners.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06494020
Start Date
September 1 2024
End Date
October 1 2027
Last Update
August 19 2025
Active Locations (2)
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1
University of Miami - Christine E. Lynn Rehabilitation Center
Miami, Florida, United States, 33136
2
University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
Miami, Florida, United States, 33136