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NCT04129242 · ClinicalTrials.gov registry record · Early Phase 1
taVNS for Upper Limb Rehabilitation
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT04129242: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT04129242 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04129242, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)
Primary Outcome
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability.
Interventions
- DEVICE Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2022-10-05 |
| Phase | Early Phase 1 |
What the finished NCT04129242 record still lists
NCT04129242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training is the first listed.
NCT04129242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04129242 about?
NCT04129242 is a clinical study titled "taVNS for Upper Limb Rehabilitation". This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients....
What is the current status of trial NCT04129242?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2020-02-19. Estimated completion is 2022-10-05.
What interventions are being tested in trial NCT04129242?
The interventions under investigation include: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training (DEVICE).
Who is sponsoring clinical trial NCT04129242?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04129242's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 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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