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Vagus Nerve Stimulation

transcutaneous auricular vagus nerve stimulation for Infant Development

Phase < 1
Waitlist Available
Led By Bashar Badran, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30min treatment session
Awards & highlights

Study Summary

This study is evaluating whether a type of nerve stimulation may help improve feeding in premature infants.

Eligible Conditions
  • Poor Appetite
  • Infant Development
  • Vagus Nerve Stimulation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30min treatment session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30min treatment session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neuroplasticity as Measured by the Change in White Matter Tract Integrity Via Fractional Anisotropy
Number of Infants Who Took All Feeds by Mouth (Responders)
ml/kg/d Increase Over 7d During taVNS
Secondary outcome measures
Number of Episodes of Bradycardia
Number of Treatment Sessions With Sustained Increase in 'Neonatal and Infant Pain Scale' (NIPS) Scores During taVNS

Trial Design

2Treatment groups
Experimental Treatment
Group I: taVNS twice dailyExperimental Treatment1 Intervention
taVNS paired with bottle feeding twice daily for 2-3 weeks
Group II: taVNS once dailyExperimental Treatment1 Intervention
taVNS paired with bottle feeding once daily for 2-3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcutaneous auricular vagus nerve stimulation
2022
Completed Early Phase 1
~100

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,600 Total Patients Enrolled
1 Trials studying Infant Development
3 Patients Enrolled for Infant Development
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
247,077 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,762 Total Patients Enrolled
6 Trials studying Infant Development
776 Patients Enrolled for Infant Development

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Frontiers in Human NeuroscienceJournal
Transcutaneous Auricular Vagus Nerve Stimulation-paired Rehabilitation for Oromotor Feeding Problems in Newborns: An Open-label Pilot Study
Badran, Bashar W., Dorothea D. Jenkins, Daniel Cook, Sean Thompson, Morgan Dancy, William H. DeVries, Georgia Mappin, Philipp Summers, Marom Bikson, and Mark S. George. 2020. “Transcutaneous Auricular Vagus Nerve Stimulation-paired Rehabilitation for Oromotor Feeding Problems in Newborns: An Open-label Pilot Study”. Frontiers in Human Neuroscience. Frontiers Media SA. doi:10.3389/fnhum.2020.00077.
Brain StimulationJournal
Transcutaneous Auricular Vagus Nerve Stimulation (tavns) for Improving Oromotor Function in Newborns
Badran, Bashar W., Dorothea D. Jenkins, William H. DeVries, Morgan Dancy, Philipp M. Summers, Georgia M. Mappin, Henry Bernstein, Marom Bikson, Patricia Coker-Bolt, and Mark S. George. 2018. “Transcutaneous Auricular Vagus Nerve Stimulation (tavns) for Improving Oromotor Function in Newborns”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2018.06.009.
clinicaltrials.govStudy
taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds
Dorothea D. Jenkins 2017. "taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04643808.
~5 spots leftby Apr 2025
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