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Chronic Transcutaneous Stimulation for Paralysis or Paresis

This study is testing a new way to help people with paralysis (loss of muscle function) or paresis (muscle weakness) due to spinal cord injury, stroke, or other brain/nerve injuries. Researchers are using an investigational neurostimulator device to deliver electrical pulses to muscles and/or the spinal column. The goal is to see if this "Transcutaneous Electrical Stimulation" can improve how well you can move your arm, hand, or leg. This early study will look at how well the device works to change muscle activity in the arm and hand over 12 months. You could be eligible if you are between 18 and 75 years old, can speak English, and are a healthy volunteer or have paralysis/paresis.

Study design
This is an interventional study with a planned enrollment of 64 participants. It is an early feasibility trial, meaning it's one of the first steps to see if this treatment is possible.
What's involved
You would attend up to 5 study sessions per week for one year, with each session lasting up to 4 hours. During sessions, electrical stimulation will be applied, and your movements will be measured.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring device feasibility is at 12 months.

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NCT04755699

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

Recruiting
EARLY_PHASE1Ages 18–75InterventionalDevice feasibility
Northwell Health
~64 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Transcutaneous Electrical Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Feasibility for Changing Muscle Activation of the Arm and Hand
Measured over 12 months

Conditions

Healthy Volunteers
Spinal Cord Injury
Stroke
Paralysis
Paresis
Neurological Injury

Explore related trials

Brachial Plexus InjuryHealthy VolunteerParkinson DiseasePeripheral Nerve InjurySpinal Cord InjuryStrokeTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Chad E Bouton, MS · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Erona Ibroci, MPH
[email protected]
516-562-3634
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
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

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

What this trial measures

  • Device Feasibility for Changing Muscle Activation of the Arm and Hand12 months

    The primary outcome will be measured as the ability for the neurostimulation device to elicit changes in muscle activation (measured by electromyography) of the arm and hand of individuals with a spinal cord injury or stroke from baseline (prior to study intervention) until study completion (after initiation of study intervention).