Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System (NCT03680872) | Clinical Trial Compass
RecruitingNot Applicable
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
United States7 participantsStarted 2019-09-30
Plain-language summary
This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System can lead to the restoration of movement and sensation in the hand and wrist of up to seven individuals with tetraplegia.
Who can participate
Age range22 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females between 22 and 65 years of age
✓. Individuals with a stable cervical spinal cord injury that have International Standards for the Neurological Classification of SCI (ISNCSCI) motor scores for fingers of 0 - 2 (non-functional) and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side
✓. Individuals at least one year from initial spinal cord injury
✓. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
✓. Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation.
✓. Individuals that are willing and able to visit the study center for study procedures that will be 1-3 sessions a week for up to 48 months at 1-4 hours per session.
✓. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
✓. Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb
Exclusion criteria
✕. Individuals participating in another research study that may affect the conduct or results of this study
✕. Individuals having or exhibiting any of the following:
✕. Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries
What they're measuring
1
Restoration of Movement
Timeframe: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
2
Restoration of Sensation
Timeframe: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.