Recruiting

taVNS & Oromotor Training

Sponsor:

Medical University of South Carolina

Code:

NCT07802301

Conditions

Dysphagia

Swallowing Disorders

Feeding and Eating Disorders of Infancy

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Oral Sensorimotor Training Protocol

Study Details

Brief summary:

This study evaluates the safety, feasibility, and preliminary effects of transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol in infants with severe dysphagia. Infants with significant sucking and swallowing impairment will receive twice-daily taVNS paired with oromotor training over a three-week period. Outcomes include swallowing mechanics, sucking proficiency, and functional feeding performance assessed before and after the intervention.

Conditions

Dysphagia

Swallowing Disorders

Feeding and Eating Disorders of Infancy

Study ID

NCT07802301

Start date

Oct 19, 2026

Status verified date

Nov, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants ≥37 weeks post-menstrual age
  • Diagnosed with dysphagia and significant sucking/swallowing impairment
  • Limited oral feeding ability
  • Admitted to NICU

Exclusion Criteria:

  • Cardiomyopathy
  • Unstable bradycardia
  • Significant respiratory support requirement
  • Absence of gag reflex
  • Inability to manage secretions
  • Infants of poorly controlled diabetic mothers

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: taVNS Paired Oromotor Training

Infants will receive transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol twice daily for 15 days over three weeks.

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

A non-invasive neuromodulation intervention delivered via electrodes placed on the ear tragus. Electrical stimulation is delivered at low intensity during feeding-related oromotor training sessions.

Oral Sensorimotor Training Protocol

A structured oromotor stimulation protocol including stimulation of lips, tongue, cheeks, and palate, along with non-nutritive sucking and feeding practice as appropriate.

Primary outcome measure

  • Change in swallowing impairment as measured by the BaByVFSImP [ Time Frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period ]
  • Change in airway protection as measured by the Penetration-Aspiration Scale [ Time Frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period ]
  • Change in early feeding skills as measured by the Early Feeding Skills Assessment [ Time Frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period ]
  • Change in sucking pressures [ Time Frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period ]
  • Change in oral feeding volume [ Time Frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period ]

Central Contacts and Locations

Central contacts

Heather C McGhee, PhD

7708834902mcghee@musc.edu

Doe Jenkins, MD

8433642662jenkd@musc.edu

Locations

Shawn Jenkins Children's Hospital

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Heather McGhee, PhD

770-883-4902mcghee@musc.edu

Doe Jenkins, MD

jenkd@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Keywords

  • Transcutaneous Auricular Vagus Nerve Stimulation
  • Oromotor Training
  • Dysphagia
  • Feeding Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.