Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injuries, Spinal Cord Injury Cervical
In brief
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.
Key facts
- Study ID
- NCT03680872
- Run by
- Chad Bouton
- People needed
- 7
- Starts
- 2019-09-30
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females between 22 and 65 years of age
- 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
- Individuals at least one year from initial spinal cord injury
- Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
- Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation.
- 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.
- Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
- Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb
You may not qualify if…
- Individuals participating in another research study that may affect the conduct or results of this study
- Individuals having or exhibiting any of the following:
- Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries
- Prior difficulties or allergy to general anesthesia
- Active wound healing or skin breakdown issues
- Stage III-IV pressure ulcers
- Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
- Prior tendon transfer to enhance hand function
- History of autoimmune disease
- Cancer
- Biochemical abnormalities of the liver, kidney, or pancreas
- Ventilator dependence
- History of serious mood or thought disorder
- Significant residual clinically evident traumatic brain injury or cognitive impairment
- Uncontrolled autonomic dysreflexia
- Spasticity in the upper extremities that is uncontrolled by pharmacological methods
- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months
- Individuals with any type of destruction and/or damage to the motor cortex region as determined by fMRI.
- History of a neurological ablation procedure
- History of hemorrhagic stroke
- History of infectious or chronic diseases, such as HIV or tuberculosis
- Individuals with any of the following co-morbid conditions that would interfere with study activities or response to treatment:
- Life expectancy < 3 years
- Severe chronic pulmonary disease
- Intractable seizure disorders
Where it is running
- Northwell Health's The Feinstein Institute for Medical Research — Manhasset, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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