Extending taVNS Paired With Infant CIMT Into a Home-Based Setting
Public ClinicalTrials.gov record NCT05857527. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Extending taVNS Paired With Infant CIMT Into a Home-Based Setting: Technology Development Requisite for a Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05857527
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 4 participants
Conditions and interventions
Conditions
Interventions
- 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
Combination Product
Eligibility (public fields only)
- Age range
- 6 Months to 18 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2023
- Primary completion
- Mar 29, 2024
- Completion
- Mar 29, 2024
- Last update posted
- Jul 3, 2025
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05857527, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 3, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05857527 live on ClinicalTrials.gov.