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NCT05101707 · ClinicalTrials.gov registry record · Early Phase 1
CIMT and taVNS for Hemiplegia in Infants
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT05101707: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT05101707 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101707, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.
Primary Outcome
Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure
Interventions
- DEVICE transcutaneous auricular vagus nerve stimulation
- OTHER Constraint induced movement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2024-02-29 |
| Phase | Early Phase 1 |
What the finished NCT05101707 record still lists
NCT05101707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which transcutaneous auricular vagus nerve stimulation is the first listed.
NCT05101707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05101707 about?
NCT05101707 is a clinical study titled "CIMT and taVNS for Hemiplegia in Infants". Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called c...
What is the current status of trial NCT05101707?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2022-04-01. Estimated completion is 2024-02-29.
What interventions are being tested in trial NCT05101707?
The interventions under investigation include: transcutaneous auricular vagus nerve stimulation (DEVICE), Constraint induced movement therapy (OTHER).
Who is sponsoring clinical trial NCT05101707?
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 NCT05101707's enrollment target sits among peer trials
6 1846th of 2000 higher than 114 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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