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RECRUITING

NCT04755699

EARLY_PHASE1

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries. In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities. During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors. The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-12-02

Completion Date

2028-06-30

Last Updated

2026-03-11

Healthy Volunteers

Yes

Conditions

Healthy Volunteers Spinal Cord Injury Stroke Paralysis Paresis Neurological Injury

Interventions

DEVICE

Transcutaneous Electrical Stimulation

The study involves the administration of various electrical pulses being delivered to muscles and/or the spinal column with an investigational neurostimulator to evoke various limb movements in order to improve functional movement.

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 to use at least one hand due to a spinal cord injury or stroke * Individuals that are at least six months from their initial stroke or one year from their 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 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 * Presence of active cancer at or near the areas of transcutaneous stimulation * History of heart or kidney disease * History of additional neurologic diseases (e.g., multiple strokes, multiple sclerosis, etc.) * Presence of other serious infections, diseases, or disorders that could affect ability to participate in this study (e.g., uncontrolled hypertension, uncontrolled diabetes, rheumatic disease, peripheral neuropathy, HIV or AIDS, etc.) * Individuals with a substance abuse (alcoholism or other) problem * Pregnant women * Prisoners

Locations (1)

Northwell Health's The Feinstein Institute for Medical Research

Manhasset, New York, United States