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

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ClinicalTrials.gov Identifier: NCT03680872
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Chad Bouton, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Injury at C5 Level Spinal Cord Injury at C5-C7 Level Spinal Cord Injury Cervical Device: Bidirectional Neural Bypass System Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

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.




Primary Outcome Measures :
  1. Restoration of Movement [ Time Frame: 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.


  2. Restoration of Sensation [ Time Frame: 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.



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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680872


Contacts
Contact: Richard D Ramdeo 516-562-3634 rramdeo1@northwell.edu

Locations
United States, New York
Northwell Health's The Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: Richard D Ramdeo    516-562-3634    rramdeo1@northwell.edu   
Principal Investigator: Chad E Bouton         
Sponsors and Collaborators
Chad Bouton
Investigators
Principal Investigator: Chad E Bouton, MS Northwell Health

Additional Information:
Publications:
Responsible Party: Chad Bouton, Vice President, Advanced Engineering; Managing Director, Center for Bioelectronic Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT03680872     History of Changes
Other Study ID Numbers: 17-0840
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, there are no plans to make individual participant data available.

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Chad Bouton, Northwell Health:
Physical and Rehabilitation Medicine
Biomedical Engineering
Paralysis
Tetraplegia
Quadriplegia
Movement Restoration
Muscle Stimulation
Tactile Sensation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations
Signs and Symptoms