RecruitingNot ApplicableNCT03680872

Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System

Sponsor

Chad Bouton

Enrollment

7 participants

Start Date

Sep 30, 2019

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries Spinal Cord Injury Cervical

Summary

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.

Eligibility

Min Age: 22 YearsMax Age: 65 Years

Inclusion Criteria8

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

Exclusion Criteria32

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
Local, systemic acute or chronic infectious illness
Life threatening cardiac arrhythmias
Severe collagen vascular disorder
Kidney failure or other major organ systems failures
Individuals with a substance abuse (alcoholism or other) problem
Pregnant women
Prisoners

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Interventions

DEVICEBidirectional Neural Bypass System

These participants will receive the investigational device called the Bidirectional Neural Bypass System. The study intends to use this device to restore volitional movement and sensation to the hand and wrist of an individual during its use in the laboratory.