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

Primary Purpose

Spinal Cord Injuries, Spinal Cord Injury Cervical

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bidirectional Neural Bypass System
Sponsored by
Chad Bouton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Physical and Rehabilitation Medicine, Biomedical Engineering, Paralysis, Tetraplegia, Quadriplegia, Movement Restoration, Muscle Stimulation, Tactile Sensation, Spinal Cord Stimulation

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females between 22 and 65 years of age
  2. 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
  3. Individuals at least one year from initial spinal cord injury
  4. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
  5. Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation.
  6. 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.
  7. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
  8. 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. Pregnant women
  6. Prisoners

Sites / Locations

  • Northwell Health's The Feinstein Institute for Medical ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Injury Participants

Arm Description

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

Outcomes

Primary Outcome Measures

Restoration of Movement
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 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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2018
Last Updated
December 28, 2022
Sponsor
Chad Bouton
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1. Study Identification

Unique Protocol Identification Number
NCT03680872
Brief Title
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Official Title
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chad Bouton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 three individuals with tetraplegia.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Injury Cervical
Keywords
Physical and Rehabilitation Medicine, Biomedical Engineering, Paralysis, Tetraplegia, Quadriplegia, Movement Restoration, Muscle Stimulation, Tactile Sensation, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Injury Participants
Arm Type
Experimental
Arm Description
This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.
Intervention Type
Device
Intervention Name(s)
Bidirectional Neural Bypass System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Restoration of Movement
Description
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.
Time Frame
The primary outcome will be assessed over the course of 12 months during the study's restoration sessions.
Title
Restoration of Sensation
Description
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.
Time Frame
The primary outcome will be assessed over the course of 12 months during the study's restoration sessions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erona Ibroci, MPH
Phone
516-562-3634
Email
eibroci@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad E Bouton, MS
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health's The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erona Ibroci, MPH
Phone
516-562-3634
Email
eibroci@northwell.edu
First Name & Middle Initial & Last Name & Degree
Chad E Bouton

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there are no plans to make individual participant data available.
Citations:
PubMed Identifier
27074513
Citation
Bouton CE, Shaikhouni A, Annetta NV, Bockbrader MA, Friedenberg DA, Nielson DM, Sharma G, Sederberg PB, Glenn BC, Mysiw WJ, Morgan AG, Deogaonkar M, Rezai AR. Restoring cortical control of functional movement in a human with quadriplegia. Nature. 2016 May 12;533(7602):247-50. doi: 10.1038/nature17435. Epub 2016 Apr 13.
Results Reference
background
PubMed Identifier
27658585
Citation
Sharma G, Friedenberg DA, Annetta N, Glenn B, Bockbrader M, Majstorovic C, Domas S, Mysiw WJ, Rezai A, Bouton C. Using an Artificial Neural Bypass to Restore Cortical Control of Rhythmic Movements in a Human with Quadriplegia. Sci Rep. 2016 Sep 23;6:33807. doi: 10.1038/srep33807.
Results Reference
background
Links:
URL
https://www.nature.com/articles/nature17435
Description
Restoring Cortical Control of Functional Movement in a Human with Quadriplegia

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

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