Task Practice and Spinal Cord Stimulation | NCT06494020

NCT06494020

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
ONWARD Medical, Inc.	INDUSTRY
United States Department of Defense	FED

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Task Practice with stimulation	Experimental	Participants in this group will receive combined Transcutaneous cervical spinal cord stimulation with task practice for up to 2 months.	Other: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test	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.	baseline, up to 4 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Spasticity as measured by Modified Ashworth Scale (MAS)	6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity.	baseline, up to 4 months

Eligibility Module

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.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations