Clinical trial NCT06494020: Task Practice and Spinal Cord Stimulation
Official title: Task Practice Combined with Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury Cervical
Spastic
Keywords: Transcutaneous
Transcutaneous Cervical Spinal Cord Stimulation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: ONWARD Medical, Inc.
First posted: 2024-07-10
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test
timeFrame: baseline, up to 6 months
Secondary outcomes:
measure: Change in Spasticity as measured by Modified Ashworth Scale (MAS)
timeFrame: baseline, up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami - Christine E. Lynn Rehabilitation Center
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: James Guest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: