Manhasset, New York 11030


Purpose:

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 three individuals with tetraplegia.


Study summary:

This study consists of the following three phases: baseline visit, surgical procedure, and restoration sessions. At the baseline visit, participants will undergo a medical history review, physical and neurological examination, functional assessment of motor and sensory capabilities, a functional magnetic resonance image (fMRI), diffusion tensor image (DTI), and a neuromuscular stimulation test. Participants deemed eligible for continued participation will then undergo a craniotomy under anesthetic sedation to implant the investigational device. The surgeon will implant microelectrode arrays into the primary motor cortex to record neural activity associated with desired movements and into the primary somatosensory cortex to deliver stimulation in order to provide sensory perception. While in surgical recovery, participants will have their vital signs monitored, be provided pain medication and antibiotics, and undergo a computed tomography (CT). The participants may also undergo electromyography and microneurography while in recovery. After being evaluated by a physician, the participants will be discharged from the hospital to continue their recovery. After fully recovering, participants will attend restoration sessions at the Feinstein Institute for Medical Research's Center for Bioelectronic Medicine. Participants will attend up to 3 study sessions a week for approximately 12 months, with each session lasting up to 4 hours. The sessions will progressively focus on identifying neural activity related to desired movements, restoring volitional control of the hand and wrist, restoring tactile perception, and then restoring volitional control and tactile perception of the hand and wrist simultaneously. The study will be considered complete after completion of enrollment (up to 3 participants), completion of study procedures by all participants, and the completion of analysis of identifiable study data.


Criteria:

Inclusion Criteria: 1. Males and females between 22 and 65 years of age 2. Individuals with AIS grade A traumatic cervical spinal cord injury with stable motor level of C5 3. Individuals who cannot sense light touch, pin prick, or pressure in their finger tips and palm (unilaterally or bilaterally) 4. Individuals at least one year from initial spinal cord injury 5. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions 6. Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation. 7. 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 12 months at 1-4 hours per session. 8. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies 9. 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. Individuals using tobacco or marijuana products 6. Pregnant women 7. Prisoners


NCT ID:

NCT03680872


Primary Contact:

Principal Investigator
Chad E Bouton, MS
Northwell Health

Richard D Ramdeo
Phone: 516-562-3634
Email: rramdeo1@northwell.edu


Backup Contact:

N/A


Location Contact:

Manhasset, New York 11030
United States

Richard D Ramdeo
Phone: 516-562-3634
Email: rramdeo1@northwell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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