Actively Recruiting
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Led by Chad Bouton · Updated on 2026-03-11
7
Participants Needed
1
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System can lead to the restoration of movement and sensation in the hand and wrist of up to seven individuals with tetraplegia.
CONDITIONS
Official Title
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females between 22 and 65 years of age
- Individuals with a stable cervical spinal cord injury with ISNCSCI motor scores for fingers of 0 - 2 and sensory scores of 0 - 2 on the palmar side
- Individuals at least one year from initial spinal cord injury
- English proficient individuals able to follow verbal commands during testing
- Able to comprehend study goals and provide informed consent
- Willing and able to visit the study center 1-3 times a week for up to 48 months, sessions lasting 1-4 hours
- Ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
- Demonstrate typical amplitude, latency, and conduction velocity in distal median, ulnar, and radial nerves of at least one upper limb
You will not qualify if you...
- Participation in another research study that may affect this study
- Medical contraindications for diffusion tensor imaging, functional MRI, electromyography, CT, cortical stimulation, or craniotomies
- Prior difficulties or allergy to general anesthesia
- Active wound healing or skin breakdown
- Stage III-IV pressure ulcers
- Chronically implanted electronic medical device (e.g., baclofen pump, deep brain stimulator, cardiac pacemaker)
- Prior tendon transfer to enhance hand function
- History of autoimmune disease
- Cancer
- Biochemical abnormalities of liver, kidney, or pancreas
- Ventilator dependence
- History of serious mood or thought disorder
- Significant residual traumatic brain injury or cognitive impairment
- Uncontrolled autonomic dysreflexia
- Pharmacologically uncontrolled spasticity in upper extremities
- Acute myocardial infarction or cardiac arrest within past 6 months
- Damage to motor cortex region as determined by fMRI
- History of neurological ablation procedure
- History of hemorrhagic stroke
- History of infectious or chronic diseases such as HIV or tuberculosis
- Co-morbid conditions interfering with study: life expectancy under 3 years, severe chronic pulmonary disease, intractable seizures, acute or chronic infections, life-threatening arrhythmias, severe collagen vascular disorder, kidney or major organ failure
- Substance abuse problems
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Actively Recruiting
Research Team
E
Erona Ibroci, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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