NCT04755699 Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
| NCT ID | NCT04755699 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Northwell Health |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2020-12-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2020-12-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Chad E Bouton, MS
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT04755699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04755699 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04755699 currently recruiting?
Yes, NCT04755699 is actively recruiting participants. Contact the research team at eibroci@northwell.edu for enrollment information.
Where is the NCT04755699 trial being conducted?
This trial is being conducted at Manhasset, United States.
Who is sponsoring the NCT04755699 clinical trial?
NCT04755699 is sponsored by Northwell Health. The principal investigator is Chad E Bouton, MS at Northwell Health. The trial plans to enroll 64 participants.