Using electrical stimulation to improve movement in people with paralysis or weakness
Official title: Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Run by Northwell Health · NCT04755699 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Status | Recruiting |
| Started | December 2, 2020 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT04755699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with physical disabilities or conditions that prevent them from completing the study tasks may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with neuromuscular stimulation techniques, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
How VR Can Make a Virtual Body Feel Real
This study tests different immersive virtual reality techniques to see which best makes a person feel the virtual body as their own, including in people with spinal cord injury or stroke.
-
Gait and Achilles Tendon Properties in Spastic Paresis
This study tests how the Achilles tendon and calf muscle function during walking in people with spastic weakness after stroke or spinal cord injury, compared with healthy individuals.
-
Spatial StimelMD for upper-limb recovery after stroke or traumatic brain injury
This trial will test whether adding the Spatial StimelMD device to standard rehabilitation helps adults with upper-limb weakness after stroke or traumatic brain injury improve arm movement.
-
Combining non-invasive brain and spinal cord stimulation to improve arm and hand function
This study tests whether pairing non-invasive brain stimulation (tDCS) with spinal cord stimulation (tSCS) during a cognitive-motor task can improve sensorimotor and cognitive-motor function in people with cervical spinal cord injury or stroke compared with each stimulation alone or sham.
-
Virtual reality plus bilateral brain stimulation to improve arm and hand recovery after stroke
We will try combining virtual reality exercises with bilateral transcranial direct current stimulation (bi‑tDCS) to improve arm and hand movement in adults at least three months after a unilateral stroke.
-
Robotic implantation of a precise brain‑computer interface to restore communication
This project tests whether a robotically implanted Neuralink N1 brain implant can help adults with severe, irreversible speech loss from ALS, spinal cord injury, or stroke communicate again.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.