Using electrical stimulation to improve movement in people with paralysis or weakness
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
This study is testing if using electrical stimulation can help people with paralysis or weakness from spinal cord injuries or strokes improve their movement.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT04755699 on ClinicalTrials.gov |
What this trial studies
This early feasibility trial investigates the effects of transcutaneous neuromuscular electrical stimulation, with or without spinal cord stimulation, on improving functional movements in individuals with paralysis or paresis resulting from spinal cord injuries or strokes. Participants will attend up to five sessions per week for a year, where their movements will be assessed through various clinical evaluations and tests. The study aims to map stimulation areas and measure improvements in arm/hand and leg/foot movements using advanced tracking and measurement techniques.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 75 with limited or no ability to use at least one hand due to spinal cord injury or stroke.
Not a fit: Patients with physical disabilities or conditions that prevent them from completing the study tasks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor function and recovery in patients with paralysis or paresis.
How similar studies have performed: Other studies have shown promise with neuromuscular stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Manhasset, New York
- Northwell Health's The Feinstein Institute for Medical Research — Manhasset, New York, United States (Recruiting)
Study contacts
- Principal investigator: Chad E Bouton, MS — Northwell Health
- Study coordinator: Erona Ibroci, MPH
- Email: eibroci@northwell.edu
- Phone: 516-562-3634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.