Task Practice and Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorUniversity of Miami
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
Other interventionHand 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Task Practice with stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, up to 4 monthsSecondary outcomes
1
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.
Time frame
baseline, up to 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
ONWARD Medical, Inc.
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov