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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
No Placebo-Only Group
Summary
This trial tests a new device called the Bidirectional Neural Bypass System, which aims to help people with severe paralysis move and feel their hands and wrists again. The device works by reading brain signals for movement and sending touch signals back to the brain. It targets individuals with tetraplegia who cannot move or feel their limbs due to spinal cord injuries.
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.
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.
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 belowSelect...
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 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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Restoration of Movement
Restoration of Sensation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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