What side effects are associated with this type of intervention?

Common treatments for spinal cord injury that aim to restore motor and sensory functions, such as neural prosthetics and electrical stimulation, can have several side effects. These may include infection at the implantation site, device malfunction, and pain or discomfort from the device. Additionally, there can be risks of nerve damage, unintended muscle contractions, and issues related to the body's immune response to the implanted device. Patients may also experience psychological effects such as anxiety or depression related to the treatment process and outcomes.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for spinal cord injury that are directly comparable to the Bidirectional Neural Bypass System, which aims to restore motor and sensory functions by bypassing damaged neural pathways. Most current treatments focus on managing symptoms and improving quality of life rather than restoring function through neural bypass. However, ongoing research and clinical trials, such as the one involving the Bidirectional Neural Bypass System, are exploring innovative approaches to address this need.

What other types of research exist?

Promising novel alternatives to the Bidirectional Neural Bypass System for spinal cord injury patients include: 1) Stem cell therapies, such as autologous mesenchymal stem cell transplantation, which have shown potential in promoting neural repair and functional recovery. 2) Neuroprosthetics, including advanced brain-computer interfaces (BCIs) that can translate neural signals into motor commands for external devices. 3) Epidural electrical stimulation (EES), which involves stimulating the spinal cord below the injury site to restore voluntary movement and improve motor function. These alternatives are currently under active research and have shown encouraging results in clinical trials.

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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 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 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

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.

0 / 5Eligibility criteria met

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.