CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 35 enrolled
Drug / intervention
transcutaneous auricular vagus nerve stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04643808
NCT04643808Early Ph 1Completed
CompareCT.gov

Noninvasive Brain Stimulation to Improve Oromotor Function In Neonates With Advanced Neuroimaging to Determine Safety and Target Engagement of taVNS for Neurorehabilitation

Medical University of South Carolina·interventional·Posted Nov 25, 2020·Updated Oct 30, 2023

In Brief

A Early Phase 1 clinical trial evaluating transcutaneous auricular vagus nerve stimulation for Poor Feeding and 2 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke. This study is designed to investigate whether transcutaneous auricular VNS (taVNS) paired with oromotor rehabilitation is tolerable, safe, and facilitates motor learning in infants who have failed oral feeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoor Feeding, Infant Development, Vagus Nerve Stimulation
CountriesUnited States
CollaboratorsNational Institute of General Medical Sciences (NIGMS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 25, 2020
Enrollment StartOct 1, 2017
Primary CompletionJun 1, 2022
Study CompletionJul 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 5.6 years ago

Interventions

transcutaneous auricular vagus nerve stimulationdevice

Microcurrent stimulation delivered to the left tragus, with stimulation 'on' during sucking from a bottle, and 'off' at rest during bottle feeding