Spastic, Spinal Cord Injury Cervical
Conditions
Keywords
Transcutaneous, Transcutaneous Cervical Spinal Cord Stimulation
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 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.
Interventions
OTHERTask Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
Hand rehabilitative tasks ( for gross hand movement, grasp and pinch tasks) will be done by participants during which time the participant will receive TcSCS. This will be done three times a week for 60 minutes.
Sponsors
University of Miami
ONWARD Medical, Inc.
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test | baseline, up to 4 months | GRASSP is a multimodal test that measures sensorimotor and prehension function in three domains that are important for the description of arm and hand functions, namely strength, sensation and prehension strength. It is an ordinal scale (minimum value = 0, maximum value = 100) with higher scores indicating better performance. There is a sensation category ordinal scale (minimum value = 0 maximum value = 24) that measures sensation where higher scores indicate greater sensation. The Prehension performance category has an ordinal scale (minimum value = 0 maximum value = 40) that measures prehension where higher scores indicate greater ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spasticity as measured by Modified Ashworth Scale (MAS) | baseline, up to 4 months | 6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Guest, MD, PhD
University of Miami
Outcome results
None listed