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

Sponsor

Chad Bouton (Other)

Overall Status

Recruiting

CT.gov ID

NCT03680872

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Spinal Cord Injury Cervical	Device: Bidirectional Neural Bypass System	N/A

Detailed Description

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 transcutaneous neuromuscular and transcutaneous spinal cord 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.

During the sessions, participants will have brain signals recorded from electrodes implanted in the brain, receive transcutaneous electrical stimulation to the arm and/or spinal cord, and receive a small amount of electrical current to the electrodes implanted in the brain. The participants may also undergo electromyography and microneurography during some of the sessions.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinal Cord Injury Participants This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.	Device: Bidirectional 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.

Arm

Intervention/Treatment

Experimental: Spinal Cord Injury Participants

This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.

Device: Bidirectional 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.

Outcome Measures

Primary Outcome Measures

Restoration of Movement [The primary outcome will be assessed over the course of 12 months during the study's restoration sessions.]
The primary outcome of restoring movement will be evaluated through Graded Redefined Assessment of Strength, Sensibility & Prehension. The performance will be graded on a numeric scale from 0-92, where a higher number indicates a better outcome. Participants will complete 10 distinct arm, wrist, and finger movements. The movements will be evaluated on a 5-point scale ranging from no movement to normal movement for a total of 0-50. Participants will be asked to perform a cylindrical grasp, key pinch, and a thumb-index pinch. The movements will be evaluated on a 4-point scale ranging from an inability to position wrist and fingers to able to perform movement with normal force for a total of 0-12. Participants will be asked to pour water, unscrew lids, place pegs on a board, open a lock, drop coins in a slot, and screw nuts. The movements will be evaluated on a 5-point scale ranging from 0% completed to 100% completed with expected grasp and no difficulties for a total of 0-30.
Restoration of Sensation [The primary outcome will be assessed over the course of 12 months during the study's restoration sessions.]
The primary outcome of restoring the perception of tactile sensation of the hand will be evaluated through the 5-Point Likert Scale. Participants will be asked whether they perceive sensation in response to objects being placed against the hand and fingertips. Participants will indicate whether they feel the object by selecting either strongly disagree (1), disagree (2), neutral (3), agree (4), or strongly agree (5). A higher total response score indicates an improvement in outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 12 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 Criteria:

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