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NCT05857527 · ClinicalTrials.gov registry record · Early Phase 1
Extending taVNS Paired With Infant CIMT Into a Home-Based Setting
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT05857527 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 4 participants.
The verdict
NCT05857527, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 4 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. taVNS stimulation will be triggered by EMG sensors which detect muscle activity. 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 6-18 months of age.
Interventions
- COMBINATION_PRODUCT Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab
- COMBINATION_PRODUCT Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2024-03-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05857527
The ClinicalTrials.gov registry entry for NCT05857527 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab is the first listed.
NCT05857527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05857527 about?
NCT05857527 is a clinical study titled "Extending taVNS Paired With Infant CIMT Into a Home-Based Setting". 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 NCT05857527?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2023-04-17. Estimated completion is 2024-03-30.
What interventions are being tested in trial NCT05857527?
The interventions under investigation include: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab (COMBINATION_PRODUCT), Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05857527?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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