← Back to Search

Neural Bypass System

Neural Bypass System for Quadriplegia

N/A

Recruiting

Led By Chad E Bouton, MS

Research Sponsored by Chad Bouton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females between 22 and 65 years of age

Individuals that are able to comprehend the study goals and procedures, and provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the primary outcome will be assessed over the course of 12 months during the study's restoration sessions.

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for individuals aged 22-65 with stable cervical spinal cord injury, specific motor and sensory scores, and normal nerve function in one upper limb. They must understand English, grasp the study's purpose, consent to it, be at least a year post-injury, and commit to visiting the study center. Exclusions include participation in conflicting studies, certain medical conditions like cancer or serious mood disorders, uncontrolled spasticity or autonomic dysreflexia, allergies to anesthesia, severe pressure ulcers among others.Check my eligibility

What is being tested?

The trial tests an investigational device called Bidirectional Neural Bypass System on up to three people with tetraplegia. It aims to restore hand and wrist movement and sensation by bypassing damaged neural pathways.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to device implantation such as infection risk at the surgical site or possible adverse responses from the nervous system due to device interaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 22 and 65 years old.

Select...

I understand the study's purpose and can agree to participate.

Select...

I am willing and able to undergo tests for my arm nerves.

Select...

I can visit the study center for all required procedures.

Select...

It has been over a year since my spinal cord injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the primary outcome will be assessed over the course of 12 months during the study's restoration sessions.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the primary outcome will be assessed over the course of 12 months during the study's restoration sessions.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary outcome will be assessed over the course of 12 months during the study's restoration sessions. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Restoration of Movement

Restoration of Sensation

Trial Design

1Treatment groups

Experimental Treatment

Group I: Spinal Cord Injury ParticipantsExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Chad BoutonLead Sponsor

Chad E Bouton, MSPrincipal InvestigatorNorthwell Health

2 Previous Clinical Trials

37 Total Patients Enrolled

Media Library

Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT03680872 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Are recruitment efforts ongoing for this medical investigation?

"Affirmative. According to clinicaltrials.gov, 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."

Answered by AI

What is the total enrollment number for this research endeavor?

"Affirmative. Clinicaltrials.gov 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."

Answered by AI

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"

Answered by AI