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

• ClinicalTrials.gov Identifier: NCT03680872
• Recruitment Status: Recruiting
• First Posted: September 21, 2018
• Last Update Posted: October 30, 2020
• Sponsor: Chad Bouton
• Information provided by (Responsible Party): Chad Bouton, Northwell Health

Tracking Information

• First Submitted Date: August 27, 2018
• First Posted Date: September 21, 2018
• Last Update Posted Date: October 30, 2020
• Actual Study Start Date: September 30, 2019
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2018)

• 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.
• 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.

Original Primary Outcome Measures (submitted: September 19, 2018)

• 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 consistent and repetitive volitional movement in the targeted muscle groups will be evaluated through the completion of GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension), which is a clinical impairment measure specific to the arm. The performance of the participant will be graded on a numeric scale based on the ease of completeness, and scored in accordance to the GRASSP manufacturer's specifications.
• 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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 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
• Study Phase: Not Applicable

Study Design

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.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Spinal Cord Injuries
• Spinal Cord Injury Cervical

Intervention

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.

Study Arms

Experimental: Spinal Cord Injury Participants

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

Intervention: Device: Bidirectional Neural Bypass System

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 19, 2018): 3
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03680872
• Other Study ID Numbers: 17-0840
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Currently, there are no plans to make individual participant data available.

• Responsible Party: Chad Bouton, Northwell Health
• Study Sponsor: Chad Bouton
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chad E Bouton, MS; Northwell Health

• PRS Account: Northwell Health
• Verification Date: October 2020