Restoring hand and wrist function in people with tetraplegia using a neural device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of the Bidirectional Neural Bypass System in restoring movement and sensation in the hands and wrists of individuals with tetraplegia. Participants will undergo a series of assessments, including medical history reviews and imaging tests, followed by a surgical procedure to implant microelectrode arrays in the brain. After recovery, they will attend multiple restoration sessions over the course of a year to assess the device's impact on their motor and sensory capabilities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males and females between 22 and 65 years of age
2. Individuals with a stable cervical spinal cord injury that have International Standards for the Neurological Classification of SCI (ISNCSCI) motor scores for fingers of 0 - 2 (non-functional) and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side
3. Individuals at least one year from initial spinal cord injury
4. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
5. Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation.
6. Individuals that are willing and able to visit the study center for study procedures that will be 1-3 sessions a week for up to 48 months at 1-4 hours per session.
7. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
8. Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb

Exclusion Criteria:

1. Individuals participating in another research study that may affect the conduct or results of this study
2. Individuals having or exhibiting any of the following:

   1. Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries
   2. Prior difficulties or allergy to general anesthesia
   3. Active wound healing or skin breakdown issues
   4. Stage III-IV pressure ulcers
   5. Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
   6. Prior tendon transfer to enhance hand function
   7. History of autoimmune disease
   8. Cancer
   9. Biochemical abnormalities of the liver, kidney, or pancreas
   10. Ventilator dependence
   11. History of serious mood or thought disorder
   12. Significant residual clinically evident traumatic brain injury or cognitive impairment
   13. Uncontrolled autonomic dysreflexia
   14. Spasticity in the upper extremities that is uncontrolled by pharmacological methods
   15. Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months
   16. Individuals with any type of destruction and/or damage to the motor cortex region as determined by fMRI.
   17. History of a neurological ablation procedure
   18. History of hemorrhagic stroke
   19. History of infectious or chronic diseases, such as HIV or tuberculosis
3. Individuals with any of the following co-morbid conditions that would interfere with study activities or response to treatment:

   1. Life expectancy \< 3 years
   2. Severe chronic pulmonary disease
   3. Intractable seizure disorders
   4. Local, systemic acute or chronic infectious illness
   5. Life threatening cardiac arrhythmias
   6. Severe collagen vascular disorder
   7. Kidney failure or other major organ systems failures
4. Individuals with a substance abuse (alcoholism or other) problem
5. Pregnant women
6. Prisoners

Where it's running

• Northwell Health's The Feinstein Institute for Medical Research
  Manhasset, New York, United States Recruiting

Study contacts

• Principal investigator: Chad E Bouton, MS — Northwell Health
• Study coordinator: Erona Ibroci, MPH
• Email: eibroci@northwell.edu
• Phone: 516-562-3634

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NG004 for incomplete cervical spinal cord injury

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.