Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Chad Bouton
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.
Description
This study consists of the following three phases: baseline visit, surgical procedure, and restoration sessions. At the baseline visit, participants will undergo a medical history review, physical and neurological examination, functional assessment of motor and sensory capabilities, a functional magnetic resonance image (fMRI), diffusion tensor image (DTI), and a transcutaneous neuromuscular and transcutaneous spinal cord stimulation test. Participants deemed eligible for continued participation will then undergo a craniotomy under anesthetic sedation to implant the investigational device. T…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females between 22 and 65 years of age 2. 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 3. Individuals at least one year from initial spinal cord injury 4. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions 5. Individuals that are able to comprehend the study goals and pr…
Interventions
- DeviceBidirectional Neural Bypass System
These participants will receive the investigational device called the Bidirectional Neural Bypass System. The study intends to use this device to restore volitional movement and sensation to the hand and wrist of an individual during its use in the laboratory.
Location
- Northwell Health's The Feinstein Institute for Medical ResearchManhasset, New York