Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorChad Bouton
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Individuals participating in another research study that may affect the conduct or results of this study
Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries
Prior difficulties or allergy to general anesthesia
Active wound healing or skin breakdown issues
Trial design
Treatments tested in this trial
- Bidirectional Neural Bypass System
Treatment groups
7 Participants
are divided into 1 treatment groupSponsors and collaborators
Chad Bouton
Lead sponsor
Northwell Health
Sponsor institution
Source ClinicalTrials.gov