Actively Recruiting
Task Practice and Spinal Cord Stimulation
Led by University of Miami · Updated on 2025-08-19
6
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
O
ONWARD Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Task Practice and Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 70 years
- Non-progressive cervical spinal cord injury
- At least 12 months post-injury
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
- Able to participate in upper extremity therapy
- GRASSP-Prehension score of 10 or higher
- MAS Score between 3 and less than 6 in at least one arm
- Commitment to study time requirements
- Stable medication profile for at least 4 weeks before enrollment
- Able to reduce Baclofen dose to 30 mg or less daily
- Able to provide informed consent
You will not qualify if you...
- Unstable or significant medical conditions interfering with study procedures, including severe neuropathic pain, depression, mood, or cognitive disorders
- Uncontrolled cardiopulmonary disease or cardiac symptoms
- Requirement for ventilator support
- Severe, unstable, and uncontrolled autonomic dysreflexia
- Autoimmune causes of spinal cord dysfunction or injury
- Previous diagnosis of transverse myelitis
- History of other neurological diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy, or seizures
- Peripheral neuropathy (e.g., diabetic polyneuropathy, entrapment neuropathy)
- Uncontrolled spasms unstable in the past three months
- Botulinum toxin injections in upper extremity, neck, or hand within six months before enrollment
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at enrollment
- Skin breakdown where electrodes will be placed
- Presence of syringomyelia confirmed by MRI
- Current cancer treatment or remission less than two years
- Stem cell treatment within past two years
- Presence of active implanted medical devices
- Participation in other drug or device trials that interfere
- Inability to consent, pregnancy, or imprisonment
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Trial Site Locations
Total: 2 locations
1
University of Miami - Christine E. Lynn Rehabilitation Center
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
N
Nilanjana Datta, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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