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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
Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb
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

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
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I am between 22 and 65 years old.
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You have normal nerve function in your hand and arm.
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I can visit the study center for all required procedures.

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.
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for spinal cord injury (SCI) include pharmacological interventions, surgical procedures, and advanced neuromodulation techniques. Pharmacological treatments aim to reduce inflammation and promote neuroprotection, while surgical interventions often focus on stabilizing the spine and decompressing neural elements. Advanced neuromodulation techniques, such as spinal cord stimulation and the Bidirectional Neural Bypass System, work by bypassing damaged neural pathways to restore motor and sensory functions. These treatments are crucial for SCI patients as they offer potential improvements in mobility, sensation, and overall quality of life, addressing the significant functional impairments caused by spinal cord injuries.
Emerging molecular therapeutic targets for spinal cord injury.

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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
~0 spots leftby Dec 2024
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