RECRUITING

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

Conditions

Spinal Cord Injuries Spinal Cord Injury Cervical Physical and Rehabilitation Medicine Biomedical Engineering Paralysis Tetraplegia Quadriplegia Movement Restoration Muscle Stimulation Tactile Sensation Spinal Cord Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-30

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03680872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Erona Ibroci, MPH

CONTACT

516-562-3634

eibroci@northwell.edu

Principal Investigator

Chad E Bouton, MS

PRINCIPAL_INVESTIGATOR

Northwell Health

Study Locations (Sites)

Northwell Health's The Feinstein Institute for Medical Research

Manhasset, New York, 11030

United States

Collaborators and Investigators

Sponsor: Chad Bouton

Chad E Bouton, MS, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-30

Study Completion Date2025-06

Study Record Updates

Study Start Date2019-09-30

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

Physical and Rehabilitation Medicine
Biomedical Engineering
Paralysis
Tetraplegia
Quadriplegia
Movement Restoration
Muscle Stimulation
Tactile Sensation
Spinal Cord Stimulation

Additional Relevant MeSH Terms

Spinal Cord Injuries
Spinal Cord Injury Cervical