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Official title Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
ClinicalTrials.gov ID: NCT04755699
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Volunteer
- 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...
- 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
You likely can't join if
- 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...
- History of epilepsy
- Chronically-implanted electronic medical device (e.g. deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
See the full eligibility criteria
Who can join
- Healthy Volunteer
- 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...
- 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...
- 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
What rules you out
- 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...
- Individuals with a substance abuse (alcoholism or other) problem
- Pregnant women
- Prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.