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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Chad Bouton
Study ID
NCT03680872
Status
Recruiting
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Conditions

  • Spinal Cord Injuries
  • Spinal Cord Injury Cervical

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study 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.

Key Dates

Start date
Sep 30, 2019
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Spinal Cord Injury Participants
    This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.

Primary Outcome Measure

Restoration of Movement [ Time Frame: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health's The Feinstein Institute for Medical ResearchManhassetNew York11030
Erona Ibroci, MPH
[email protected]
5165623634
Chad E Bouton (PRINCIPAL_INVESTIGATOR)

Find similar trials in Manhasset, NY

By research site
Northwell Health's The Feinstein Institute for Medical Research· Manhasset, NY

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