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

Launched by NORTHWELL HEALTH · Feb 12, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new method to help people with paralysis or weakness in their arms or legs improve their movement. It uses a special device that sends electrical signals to stimulate the muscles and nerves. The goal is to see if this treatment can help people who have had spinal cord injuries, strokes, or other nerve-related injuries regain some function in their limbs. The trial is currently recruiting participants who are between 18 and 75 years old, including healthy volunteers and those with specific injuries that limit their ability to move.

Participants will attend up to five sessions a week for a year, with each session lasting up to four hours. During these visits, they will undergo various assessments to measure their movement and sensation, followed by exercises designed to stimulate their limbs. Throughout the study, researchers will monitor any changes in their ability to move. It’s important for potential participants to be able to follow instructions in English and be willing to commit to the study schedule. If you or someone you know meets the eligibility criteria and is interested in participating, this trial could provide an opportunity to explore new ways to improve mobility after an injury.

Gender

ALL

Eligibility criteria

• 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