Bidirectional Neural Bypass System for Spinal Cord Injury

Phase-Based Progress Estimates
Northwell Health's The Feinstein Institute for Medical Research, Manhasset, NYSpinal Cord Injury+1 MoreBidirectional Neural Bypass System - Device
22 - 65
All Sexes
What conditions do you have?

Study Summary

This trial will test whether an investigational device can help people with tetraplegia regain movement and sensation in their hand and wrist.

Eligible Conditions
  • Spinal Cord Injury Cervical (SCI-C)
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: The primary outcome will be assessed over the course of 12 months during the study's restoration sessions.

Month 12
Restoration of Movement
Restoration of Sensation

Trial Safety

Trial Design

1 Treatment Group

Spinal Cord Injury Participants
1 of 1

Experimental Treatment

3 Total Participants · 1 Treatment Group

Primary Treatment: Bidirectional Neural Bypass System · No Placebo Group · N/A

Spinal Cord Injury Participants
Experimental Group · 1 Intervention: Bidirectional Neural Bypass System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the primary outcome will be assessed over the course of 12 months during the study's restoration sessions.

Who is running the clinical trial?

Chad BoutonLead Sponsor
Chad E Bouton, MSPrincipal InvestigatorNorthwell Health
2 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 22 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a spinal cord injury at least one year ago.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
< 18100.0%
What site did they apply to?
Northwell Health's The Feinstein Institute for Medical Research100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Is this clinical trial open to participants younger than 45 years old?

"To participate in this study, qualified applicants must be between the ages of 22 and 65. Alternatively, there are 138 trials for individuals below the age of majority, and 742 studies available for those aged over 65 years old." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts ongoing for this medical investigation?

"Affirmative. According to, this experiment is currently conscripting test subjects - it was initially uploaded on September 30th 2019 with its most recent update being November 15 2021. It requires 3 individuals from one medical centre for participation in the trial." - Anonymous Online Contributor

Unverified Answer

What is the total enrollment number for this research endeavor?

"Affirmative. displays data affirming the recruitment of patients for this trial, which was first posted on September 30th 2019 and subsequently updated November 15th 2021. The medical study requires 3 people to be enrolled at a single location." - Anonymous Online Contributor

Unverified Answer

What criteria must be met in order for a person to qualify as a participant in this medical experiment?

"The trial is searching for 3 individuals aged between 22 and 65 with a spinal cord injury that meet the following criteria: gender agnostic, ISNCSCI motor scores of 0-2 (non-functional) on their fingers and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side, ability to undertake upper limb electrodiagnostic & nerve conduction studies, at least one year post SCI trauma, English proficiency to follow verbal commands in testing sessions as well as understanding study goals/ procedures and providing consent for participation. Additionally, those eligible must demonstrate typical amplitude, latency & conduction velocity in dist" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.