Status:
RECRUITING
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Lead Sponsor:
Northwell Health
Conditions:
Healthy Volunteers
Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimu...
Detailed Description
During study sessions, both neuromuscular and spinal cord stimulation will first be manually administered to properly map the area in relation to intended movements. Once mapping for placement is comp...
Eligibility Criteria
Inclusion
- Healthy Volunteer Inclusion Criteria:
- Individuals between 18 and 75 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 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 may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session
- Stroke and Spinal Cord Injury Participant Inclusion Criteria:
- Individuals between 18 and 75 years of age
- Individuals with a limited ability or no ability to use at least one hand due to a spinal cord injury or stroke
- Individuals that are at least one year from their initial stroke or 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 may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session
- Brain or Nerve Injury Participant Inclusion Criteria:
- Individuals between 18 and 75 years of age
- Individuals with a limited ability or no ability to use at least one limb due to a brain or nerve injury such as a traumatic brain injury, brachial plexus injury, peripheral nerve damage, or Parkinson's Disease.
- 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 may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session
- Exclusion Criteria for All Study Participants:
- Individuals participating in another study that may affect the conduct or results of this study
- Individuals having or exhibiting any of the following, as specified by self-report:
- Stage III-IV pressure ulcers that adversely interfere with study involvement (i.e., pressure ulcer on the extremity of interest or prohibits extended bouts of sitting)
- History of epilepsy
- Chronically-implanted electronic medical device (e.g. deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
- Abnormalities of the arms/hands, legs/feet, or spinal column that would prevent electrical stimulation
- Ventilator dependence
- History of serious mood or thought disorder
- Uncontrolled autonomic dysreflexia
- Severe spasticity in extremities of interest that are uncontrolled by pharmacological methods or prevents electrical stimulation
- Botulinum toxin injections to the extremity of interest within 3 months
- Individuals with a substance abuse (alcoholism or other) problem
- Pregnant women
- Prisoners
Exclusion
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04755699
Start Date
December 2 2020
End Date
June 30 2026
Last Update
January 19 2024
Active Locations (1)
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1
Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030