Status:
COMPLETED
Evaluating Neuromuscular Stimulation for Restoring Hand Movements
Lead Sponsor:
Northwell Health
Conditions:
Healthy Volunteers
Spinal Cord Injury Cervical
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement ...
Detailed Description
In order to evaluate whether electrical stimulation applied to the muscles within the forearm can evoke functional movement in the hand, participants will receive transcutaneous electrical stimulation...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Health Volunteers:
- Individuals between 18 and 65 years of age
- Individuals without physical disabilities or conditions/diseases that may make them incapable of completing the physical study tasks or otherwise places them at a greater risk of harm
- 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, which will be up to 4 sessions a week for up to 8 weeks at up to 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 for Healthy Volunteers:
- Individuals participating in another research study that may affect the conduct or results of this study
- Individuals having or exhibiting any of the following:
- 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
- Prior difficulties or allergy to general anesthesia
- 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
- Individuals with a substance abuse (alcoholism or other) problem
- Pregnant women
- Prisoners
- Inclusion Criteria for Participants with a Spinal Cord Injury:
- Individuals between 18 and 65 years of age
- Individuals with a stable cervical spinal cord injury with ISNCSCI motor scores for fingers of 0 - 2 (non-functional), and 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, which will be up to 4 sessions a week for up to 8 weeks at up to 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 (as expected for a person at their stage of time post spinal cord injury)
- Exclusion Criteria for Participants with a Spinal Cord Injury:
- Individuals participating in another research study that may affect the conduct or results of this study
- Individuals having or exhibiting any of the following:
- 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
- Prior difficulties or allergy to general anesthesia
- 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
- Individuals with a substance abuse (alcoholism or other) problem
- Pregnant women
- Prisoners
Exclusion
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03385005
Start Date
September 15 2017
End Date
October 1 2023
Last Update
October 10 2023
Active Locations (1)
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1
Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030