RecruitingNot Applicable

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

United States7 participantsStarted 2019-09-30

Plain-language 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.

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Individuals participating in another research study that may affect the conduct or results of this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Restoration of Movement

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

Restoration of Sensation

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

Trial details

NCT IDNCT03680872

SponsorChad Bouton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Erona Ibroci, MPH

516-562-3634 eibroci@northwell.edu

View on ClinicalTrials.gov More Spinal Cord Injuries trials