Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System

NCT03680872 | Recruiting DMC FDA Device

• 1 other identifier: 17-0840
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spinal Cord Injury Cervical

Keywords

Physical and Rehabilitation Medicine; Biomedical Engineering; Paralysis; Tetraplegia; Quadriplegia; Movement Restoration; Muscle Stimulation; Tactile Sensation; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.

• 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.

  The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.

Study Arms (1)

Spinal Cord Injury Participants

EXPERIMENTAL

This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.

Device: Bidirectional Neural Bypass System

Interventions

Bidirectional Neural Bypass System DEVICE

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.

Spinal Cord Injury Participants

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation.
• 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.
• Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
• Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb

You may not qualify if:

• Individuals participating in another research study that may affect the conduct or results of this study
• Individuals having or exhibiting any of the following:
• 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
• Stage III-IV pressure ulcers
• Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
• Prior tendon transfer to enhance hand function
• History of autoimmune disease
• Cancer
• Biochemical abnormalities of the liver, kidney, or pancreas
• Ventilator dependence
• History of serious mood or thought disorder
• Significant residual clinically evident traumatic brain injury or cognitive impairment
• Uncontrolled autonomic dysreflexia

Sponsors & Collaborators

• Chad Bouton: lead

Study Sites (1)

Northwell Health's The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

RECRUITING

Related Publications (2)

• Bouton CE, Shaikhouni A, Annetta NV, Bockbrader MA, Friedenberg DA, Nielson DM, Sharma G, Sederberg PB, Glenn BC, Mysiw WJ, Morgan AG, Deogaonkar M, Rezai AR. Restoring cortical control of functional movement in a human with quadriplegia. Nature. 2016 May 12;533(7602):247-50. doi: 10.1038/nature17435. Epub 2016 Apr 13.

  PMID: 27074513 BACKGROUND

• Sharma G, Friedenberg DA, Annetta N, Glenn B, Bockbrader M, Majstorovic C, Domas S, Mysiw WJ, Rezai A, Bouton C. Using an Artificial Neural Bypass to Restore Cortical Control of Rhythmic Movements in a Human with Quadriplegia. Sci Rep. 2016 Sep 23;6:33807. doi: 10.1038/srep33807.

  PMID: 27658585 BACKGROUND

Related Links

• Restoring Cortical Control of Functional Movement in a Human with Quadriplegia

MeSH Terms

Conditions

Spinal Cord Injuries; Paralysis; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad E Bouton, MS

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erona Ibroci, MPH

CONTACT

516-562-3634; eibroci@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President, Advanced Engineering; Managing Director, Center for Bioelectronic Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 21, 2018
• Study Start: September 30, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)