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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Bidirectional Neural Bypass System
DeviceThese 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.
Treatment groups
7 Participants
are divided into 1 treatment groupGroup A: Spinal Cord Injury ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Restoration of Movement
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.
Time frame
The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.2
Restoration of Sensation
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.
Time frame
The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chad Bouton
Lead sponsor
Northwell Health
Sponsor institution
Source ClinicalTrials.gov