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NCT03385005 · ClinicalTrials.gov registry record · Early Phase 1
Evaluating Neuromuscular Stimulation for Restoring Hand Movements
A Early Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
NCT03385005: Completed Early Phase 1 study, sponsored by Northwell Health.
NCT03385005 is a Early Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 9 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03385005, a Early Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. The primary purpose of this study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm. It is believed that this study will be able to identify specific stimulation parameters and electrode spatial configurations responsible for various refined hand movements. After an eligible individual agrees to participate in this study, s/he will receive transcutaneous electrical stimulation on the forearm in order to evoke different hand and finger movements. The precision, specificity, and extent of these movements will be visually assessed. In order to better evaluate these movements, participants may also be asked to perform various functional tasks with their hand. The grip strength and evoked forces at the fingertips will also be measured using sensors. There will be up to 4 study sessions each week for up to 8 weeks, with each session lasting up to 4 hours. Upon completion of these study sessions, the individual's participation in the study is considered complete.
Primary Outcome
The primary outcome measure will be achievable wrist and finger movements that will be visually assessed for the type and extent of motion in relation to the stimulation parameters and electrode spatial configurations. The extent of wrist, forearm, and individual finger movements will be categorized as either flexion, extension, adduction, abduction, pronation, or supination and graded as no movement, slight movement, moderate movement, or substantial movement.
Interventions
- DEVICE Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2023-10-01 |
| Phase | Early Phase 1 |
What the finished NCT03385005 record still lists
NCT03385005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. is the first listed.
NCT03385005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03385005 about?
NCT03385005 is a clinical study titled "Evaluating Neuromuscular Stimulation for Restoring Hand Movements". The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. The primary purpose of this study is to determine the feasibility of achieving refin...
What is the current status of trial NCT03385005?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2017-09-15. Estimated completion is 2023-10-01.
What interventions are being tested in trial NCT03385005?
The interventions under investigation include: Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. (DEVICE).
Who is sponsoring clinical trial NCT03385005?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03385005's enrollment target sits among peer trials
9 1746th of 2000 higher than 219 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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