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taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds

NCT04643808 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-10-30

Study results available
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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.

Conditions

  • Poor Feeding
  • Infant Development
  • Vagus Nerve Stimulation

Interventions

DEVICE

transcutaneous auricular vagus nerve stimulation

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

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Dorothea Jenkins, MD · Medical University of South Carolina

  • Bashar Badran, PhD · Medical University of South Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
3 Weeks
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2022-06-01
Completion
2022-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643808 on ClinicalTrials.gov