No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Device Feasibility
Participants needed
64 (estimated)
Sponsor
Northwell Health · Other
Who this trial is looking for
This trial is looking for individuals with paralysis or limited movement due to stroke, spinal cord injury, or other brain or nerve injuries. Participants will attend study sessions that involve electrical stimulation aimed at improving arm, hand, or leg movements.
Are You a Good Fit for This Trial?
Rules you outHistory of serious mood or thought disorderHistory of heart diseaseHistory of kidney diseaseHistory of multiple strokesHistory of multiple sclerosis
You may be able to join if
I am between 18 and 75 years old
I have limited or no ability to use at least one limb
I can understand and follow verbal instructions in English
I can provide informed consent for participation
I can attend up to 5 study sessions a week for at least 2 months
You may not be able to join if
I am participating in another study that could affect this trial
I have a history of epilepsy
I have severe pressure ulcers that affect my participation
I have a chronic medical device implanted in my body
I have serious mood or thought disorders
I have uncontrolled high blood pressure
I am pregnant
I have a substance abuse problem
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 individual…
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.
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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 conside…
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
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