Restoring Hand Function with a Neural Bypass System for Spinal Cord Injury
This study is testing an investigational device called the Bidirectional Neural Bypass System. It aims to restore movement and sensation in the hand and wrist for people with tetraplegia (paralysis affecting all four limbs) due to a cervical spinal cord injury. Researchers will implant this device to record brain signals for movement and deliver stimulation for sensation. The study is looking for up to seven participants, aged 22 to 65, who have limited or no hand movement and sensation due to their spinal cord injury. Success in this study means seeing a restoration of movement and sensation in the hand and wrist. The current recruitment status is unclear.
- Study design
- This is an early feasibility study involving up to 7 participants. It is a single-cohort interventional study.
- What's involved
- You would have a baseline visit, a surgical procedure to implant the device, and then attend restoration sessions over 48 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your movement and sensation will be assessed over 48 months during the restoration sessions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Chad E Bouton, MS · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Restoration of MovementThe primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
The primary outcome of restoring movement will be evaluated through Graded Redefined Assessment of Strength, Sensibility \& Prehension. The performance will be graded on a numeric scale from 0-92, where a higher number indicates a better outcome. Participants will complete 10 distinct arm, wrist, and finger movements. The movements will be evaluated on a 5-point scale ranging from no movement to normal movement for a total of 0-50. Participants will be asked to perform a cylindrical grasp, key pinch, and a thumb-index pinch. The movements will be evaluated on a 4-point scale ranging from an inability to position wrist and fingers to able to perform movement with normal force for a total of 0-12. Participants will be asked to pour water, unscrew lids, place pegs on a board, open a lock, drop coins in a slot, and screw nuts. The movements will be evaluated on a 5-point scale ranging from 0% completed to 100% completed with expected grasp and no difficulties for a total of 0-30.
- Restoration of SensationThe primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
The primary outcome of restoring the perception of tactile sensation of the hand will be evaluated through the 5-Point Likert Scale. Participants will be asked whether they perceive sensation in response to objects being placed against the hand and fingertips. Participants will indicate whether they feel the object by selecting either strongly disagree (1), disagree (2), neutral (3), agree (4), or strongly agree (5). A higher total response score indicates an improvement in outcome.