Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
This study tests a new device called the Bidirectional Neural Bypass System that aims to help people with tetraplegia (paralysis affecting all four limbs) regain the ability to move and feel their hands and wrists. The device works by creating a new pathway for signals between the brain and hand, bypassing the damaged spinal cord. Up to seven participants will receive the device to see if it can restore hand function and sensation.
Key Objective:This trial is testing whether the Bidirectional Neural Bypass System can restore voluntary movement and touch sensation in the hands of people with tetraplegia.
Who to Consider:People with tetraplegia who want to explore a new technology that may help restore hand and wrist function and sensation should consider enrolling in this study.
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 procedures, and are able to provide informed consent for participation. 6. 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. 7. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies 8. Demonstrate typical amplitude, latency, and conduction v