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NCT04755699 · ClinicalTrials.gov registry record · Early Phase 1
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
A Early Phase 1 study of Stroke and Healthy Volunteers, sponsored by Northwell Health.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04755699: Recruiting Early Phase 1 study of Stroke and Healthy Volunteers, sponsored by Northwell Health.
NCT04755699 is a Early Phase 1 study of Stroke and Healthy Volunteers that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 64 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04755699, a Early Phase 1 study of Stroke and Healthy Volunteers, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE Transcutaneous Electrical Stimulation
Study Locations (1)
New York
- Northwell Health's The Feinstein Institute for Medical Research - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2028-06-30 |
| Phase | Early Phase 1 |
What NCT04755699 shows while recruiting
NCT04755699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower).
The record links to 6 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous Electrical Stimulation is the first listed.
NCT04755699 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04755699 about?
NCT04755699 is a clinical study titled "Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis". 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...
What is the current status of trial NCT04755699?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 64 participants. The study started on 2020-12-02. Estimated completion is 2028-06-30.
What conditions does trial NCT04755699 study?
This clinical trial studies the following conditions: Stroke, Healthy Volunteers, Spinal Cord Injury, Paralysis, Neurological Injury.
What interventions are being tested in trial NCT04755699?
The interventions under investigation include: Transcutaneous Electrical Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04755699?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04755699 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04755699's enrollment target sits among peer trials
64 198th of 454 higher than 255 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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