Combining task practice with spinal cord stimulation for spasticity management
Task Practice Combined With Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury
This study is testing if combining physical therapy with spinal cord stimulation can help people with cervical spinal cord injuries reduce muscle stiffness and improve their movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 22 Years to 70 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06494020 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of combining task practice with transcutaneous cervical spinal cord stimulation (TcSCS) on individuals with cervical spinal cord injuries. It will specifically explore how higher stimulation frequencies may influence spasticity and hypertonicity in patients. Participants will engage in upper extremity therapy while receiving stimulation, allowing researchers to assess improvements in motor function and spasticity levels. The study targets individuals who are at least 12 months post-injury and have specific impairment classifications.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 22-70 with non-progressive cervical spinal cord injuries who have been stable for at least 12 months.
Not a fit: Patients with unstable medical conditions, severe cognitive disorders, or those requiring ventilator support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved motor function and reduced spasticity for patients with cervical spinal cord injuries.
How similar studies have performed: Previous studies have shown that transcutaneous spinal cord stimulation can improve motor function, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Criteria: * 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.
Where this trial is running
Miami, Florida and 1 other locations
- University of Miami - Christine E. Lynn Rehabilitation Center — Miami, Florida, United States (Recruiting)
- University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: James Guest, MD, PhD — University of Miami
- Study coordinator: Nilanjana Datta, MD
- Email: nx693@med.miami.edu
- Phone: 3052436798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.