Neural Bypass System for Quadriplegia

Overseen By Erona Ibroci, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chad Bouton

Disqualifiers: Cancer, Autoimmune disease, Serious mood disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called the Bidirectional Neural Bypass System to determine if it can restore movement and feeling in the hands and wrists of people with tetraplegia (paralysis of all four limbs). The main goal is to assess whether this device can significantly benefit those with spinal cord injuries. Participants should have a stable spinal cord injury affecting their neck, resulting in limited hand movement and feeling, and must be able to visit the study center regularly for up to 12 months.

As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research that could transform lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a chronically-implanted electronic medical device or uncontrolled spasticity, you may not be eligible to participate.

What prior data suggests that the Bidirectional Neural Bypass System is safe for individuals with tetraplegia?

Research has shown that the Bidirectional Neural Bypass System is generally well-tolerated. Early studies have found that this device can help people with severe paralysis regain movement and touch. In one case, a participant experienced improved movement and sensation without serious side effects. This outcome suggests the device is safe for humans, at least in the short term. However, as this is an early trial to test feasibility, further research is needed to confirm long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bidirectional Neural Bypass System is unique because it offers a groundbreaking approach for individuals with quadriplegia by directly linking the brain and spinal cord to restore movement and sensation. Most current treatments for spinal cord injuries focus on rehabilitation, assistive devices, or medications to manage symptoms, but they don't directly reconnect the brain's signals to the muscles. This system uses advanced technology to create a new pathway for nerve signals, potentially allowing for more natural and voluntary movement. Researchers are excited because this could mean a significant improvement in quality of life for those affected, offering hope for regaining independence and function.

What evidence suggests that the Bidirectional Neural Bypass System is effective for tetraplegia?

Research has shown that the Bidirectional Neural Bypass System, which participants in this trial will receive, can help people with paralysis regain movement and sensation. This system functions as an electronic bridge, enabling signals to travel between the brain and paralyzed parts of the body. This connection can restore movement and feeling. Early results are promising, with some individuals gaining better control over their hands. The system also enhances prosthetic function for those with paralysis, making everyday tasks easier. Overall, this new approach offers hope for improving life for people with spinal cord injuries. ^{1 3 5 6 7}

Who Is on the Research Team?

Chad E Bouton, MS

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Individuals that are considered English Proficient due to the study requirements

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

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

Exclusion Criteria

You rely on a ventilator to help you breathe.

You have other health problems that could make it difficult for you to take part in the study or respond to the treatment.

I had a heart attack or cardiac arrest in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Visit

Participants undergo a medical history review, physical and neurological examination, functional assessment, fMRI, DTI, and stimulation tests

1 week

1 visit (in-person)

Surgical Procedure

Participants undergo craniotomy to implant the investigational device and are monitored during recovery

2 weeks

Hospital stay

Restoration Sessions

Participants attend sessions to identify neural activity, restore volitional control, and tactile perception

12 months

Up to 3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bidirectional Neural Bypass System

Trial Overview 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.

How Is the Trial Designed?

Group I: Spinal Cord Injury Participants Experimental Treatment 1 Intervention

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

Bidirectional Neural Bypass System is already approved in United States for the following indications:

Approved in United States as Bidirectional Neural Bypass System for:

• Restoration of movement and sensation in the hand and wrist of individuals with tetraplegia

Who Is Running the Clinical Trial?

Chad Bouton

Lead Sponsor

Trials

1

Recruited

3+

Published Research Related to This Trial

Sacral neuromodulation (SNM) was found to be effective in treating neurogenic bladder and bowel dysfunction in 33 patients with spina bifida, achieving a success rate of approximately 69.7% during a 14-28 day experiential treatment period without complications.

Patients experienced significant improvements in urinary symptoms, such as reduced urgency and leakage, as well as enhanced urodynamic parameters, indicating that SNM can help prevent upper urinary tract damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of sacral neuromodulation on neurogenic bladder and bowel dysfunction in patients with spina bifida]. Chen, G., Wang, Y., Ying, X., et al.[2022]

The study introduces a phenotype-based approach to managing neurogenic bladder (NGB) in patients with conditions like spinal cord injury, spina bifida, cerebral palsy, and multiple sclerosis, emphasizing tailored surgical options based on individual patient needs.

It highlights the importance of considering factors such as social support and physical condition when selecting surgical interventions, suggesting that a holistic approach can improve outcomes for patients with NGB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurogenic Bladder:: Assessment and Operative Management. DeWitt-Foy, ME., Elliott, SP.[2022]

In a study of 14 patients undergoing surgery for extensive thoracoabdominal aneurysms, the use of distal aortic perfusion significantly reduced the mean spinal cross-clamp time from 47.2 minutes to 23.4 minutes, which may help prevent spinal cord ischemia during surgery.

All patients survived the operation, and while there were some complications, including a 21% mortality rate and two cases of paraplegia, no major cardiac or renal complications were reported, indicating that the approach is relatively safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of spinal cord ischemia in surgery of thoraco-abdominal aneurysms. The Bio Medicus pump, the recording of somatosensory evoked potentials and the impact on surgical strategy. de Mol, B., Hamerlijnck, R., Boezeman, E., et al.[2019]

Veno-arterial bypass (VAB) effectively maintains spinal cord blood flow during aortic cross-clamping for up to one hour, as indicated by stable somatosensory evoked potentials (SEPs) when distal arterial pressure is kept above 60 mmHg.

The study demonstrated that using VAB without systemic heparinization can protect spinal cord function during surgery, with no postoperative gait abnormalities observed in the dogs, suggesting a safe and effective method for preventing paraplegia during thoracic aneurysm surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preservation of spinal cord function and prevention of paralysis during aortic occlusion via veno-arterial bypass. Grossi, EA., Krieger, KH., Cunningham, JN., et al.[2016]

In a study of 37 patients undergoing surgery for thoracic and thoracoabdominal aortic aneurysms, a regional spinal cord cooling system was used, resulting in no cases of neurological deficits such as paraplegia or paraparesis post-surgery.

The technique showed promising outcomes with a low hospital mortality rate of 5.4%, suggesting that spinal cord cooling may enhance safety during complex aortic repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic and thoracoabdominal aortic repair under regional spinal cord hypothermia. Shimizu, H., Mori, A., Yoshitake, A., et al.[2014]

A patient developed unilateral neurological symptoms resembling Brown-Séquard syndrome after the removal of a cerebrospinal fluid (CSF) drainage catheter following thoracic aortic surgery, indicating a potential spinal cord injury during the procedure.

Reinserting the CSF catheter and draining the fluid led to a full neurological recovery, suggesting that careful management of CSF drainage can be crucial in preventing and addressing postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brown-Séquard syndrome following removal of a cerebrospinal fluid drainage catheter after thoracic aortic surgery. Puchakalaya, MR., Tremper, KK.[2021]

Transcutaneous electrical nerve stimulation (TENS) combined with anticholinergic drugs significantly improved symptoms of neurogenic bladder in patients with spina bifida, leading to a notable reduction in wet episodes per day and improved bladder function metrics.

In a study of 40 patients, those receiving TENS with anticholinergic medications (Group C) showed the greatest improvements in detrusor pressure, bladder compliance, and capacity compared to those receiving placebo treatments or TENS alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation in Management of Neurogenic bladder Secondary to Spina Bifida. Pattanshetti, S., Mahajan, JK., Saxena, S., et al.[2022]

Diagnosing neurogenic bladder in children with conditions like myelomeningocele is easier than in those with occult dysraphism or central nervous system disorders, where clinical examination and urodynamic testing are essential for accurate diagnosis and management.

Effective management of neurogenic bladder involves a combination of medical and surgical treatments, including intermittent catheterization, anticholinergic drugs, and various surgical techniques, with a focus on preserving upper urinary tract function and improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurogenic bladder in children: basic principles, new therapeutic trends. Guys, JM., Hery, G., Haddad, M., et al.[2017]

In a study of 100 patients with neurogenic bladder after spinal cord injury, both magnetic stimulation of sacral nerve roots and Tui-na therapy were effective in improving bladder function and quality of life.

The combination of magnetic stimulation and Tui-na showed superior results compared to either treatment alone, indicating a synergistic effect that enhances urinary system function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the magnetic stimulation of sacral nerve roots combined with Tui-na on neurogenic bladder after spinal cord injury: preliminary short-term results. Chen, L., Li, Y.[2023]

In a study involving 6 dogs, interrupting segmental arteries at up to three levels resulted in a decrease in spinal cord blood flow (SCBF) but did not lead to any significant changes in spinal cord function or neurological status.

The findings suggest that preoperative embolization of segmental arteries to minimize blood loss during spinal tumor surgeries may be safe, as it did not compromise spinal cord function in the experimental model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence on spinal cord blood flow and function by interruption of bilateral segmental arteries at up to three levels: experimental study in dogs. Ueda, Y., Kawahara, N., Tomita, K., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2019-313ec

Neural Bypass System for Quadriplegia This approach allows for bidirectional communication, potentially restoring voluntary movement and sensation in individuals with quadriplegia. Show more.

2. feinstein.northwell.edu feinstein.northwell.edu/news/the-latest/bioelectronic-medicine-researchers-restore-feeling-lasting-movement-in-man-living-with-quadriplegia

Double neural bypass restores movement, sense of touch ... This double neural bypass forms an electronic bridge that allows information to flow once again between the man's paralyzed body and brain to restore movement ...

3. lidsen.com lidsen.com/journals/neurobiology/neurobiology-07-01-158

Neural Bypasses: Literature Review and Future Directions ... Overall, neural bypasses are a promising modality to improve the treatment of common neurologic disorders, including stroke, spinal cord injury, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1571064525001265

Neural decoding reliability: Breakthroughs and potential of ... This bidirectional BCI system not only significantly improves the functionality and efficiency of prosthetics by paraplegic patients, but also demonstrates ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11100864/

An Investigation of Manifold-Based Direct Control for a ... Objective: Brain-body interfaces (BBIs) have emerged as a very promising solution for restoring voluntary hand control in people with upper-limb paralysis.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/197561

Restoring Motor and Sensory Hand Function in Tetraplegia ... This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.08.19.25330198v1.full.pdf

Restoring Cortically Mediated Movement and Sensation in ... Here, we demonstrate an artificial 'double neural bypass' (DNB) that integrates a bidirectional intracortical brain- computer interface with ...