Neural Bypass System for Quadriplegia

Overseen by Chad E Bouton, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Chad Bouton

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Bidirectional Neural Bypass System for quadriplegia?

The research does not directly address the effectiveness of the Bidirectional Neural Bypass System for quadriplegia, but it mentions sacral neuromodulation, which has shown promising results in managing neurogenic bladder, a condition related to nerve damage. This suggests that similar neural modulation techniques might be beneficial for other nerve-related conditions. ^{1 2 3 4 5}

How is the Neural Bypass System treatment for quadriplegia different from other treatments?

The Neural Bypass System is unique because it creates a direct connection between the brain and muscles, bypassing damaged spinal cord areas, which is not addressed by traditional treatments. This approach allows for bidirectional communication, potentially restoring voluntary movement and sensation in individuals with quadriplegia. ^{6 7 8 9 10}

Research Team

Chad E Bouton, MS

Principal Investigator

Northwell Health

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Bidirectional Neural Bypass System (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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Chad Bouton

Lead Sponsor

Trials

1

Recruited

3+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neurogenic Bladder:: Assessment and Operative Management. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of sacral neuromodulation on neurogenic bladder and bowel dysfunction in patients with spina bifida]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Neurogenic bladder in children: basic principles, new therapeutic trends. [2017]

4. India pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation in Management of Neurogenic bladder Secondary to Spina Bifida. [2022]

5. Germany 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. [2023]

6. Germany 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. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Preservation of spinal cord function and prevention of paralysis during aortic occlusion via veno-arterial bypass. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Thoracic and thoracoabdominal aortic repair under regional spinal cord hypothermia. [2014]

10. United States 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. [2019]