taVNS in Infants Severe Dysphagia

NCT07802301 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Pro00150100
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Change in swallowing impairment as measured by the BaByVFSImP

  Swallowing mechanics will be assessed using the Baby Videofluoroscopic Swallow Study Impairment Profile, a standardized scoring tool used to evaluate physiologic components of infant swallowing during videofluoroscopic swallow study. Scores will be compared from pre-treatment to post-treatment to determine change in swallowing impairment. Lower scores indicate less impairment.

  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

  Airway protection during swallowing will be assessed using the Penetration-Aspiration Scale from videofluoroscopic swallow study recordings. Scores describe the depth of airway invasion and the infant's response to material entering the airway. Scores will be compared from pre-treatment to post-treatment. Lower scores indicate better airway protection.

  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

  Feeding skills will be assessed using the Early Feeding Skills Assessment, a standardized clinical assessment used to evaluate infant feeding readiness, oral feeding skills, physiologic stability, and feeding tolerance. Scores will be compared from pre-treatment to post-treatment to evaluate change in functional feeding performance. Higher scores indicate more mature or more effective feeding skills.

  Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period

• Change in sucking pressures

  Sucking pressures will be measured. Values will be compared from pre-treatment to post-treatment to evaluate change in sucking mechanics.

  Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period

• Change in oral feeding volume

  Oral feeding volume will be measured as the amount of prescribed feeding volume taken orally. Oral intake volume will be compared from pre-treatment to post-treatment to determine change in functional oral feeding ability. Greater oral intake volume indicates improved feeding performance.

  Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period

Secondary Outcomes (6)

• Number of bradycardia events during intervention

  During each intervention session throughout the 3-week intervention period

• Number of oxygen desaturation events during intervention

  During each intervention session throughout the 3-week intervention period

• Number of coughing or choking episodes during intervention

  During each intervention session throughout the 3-week intervention period

• Intervention completion rate

  End of the 3-week intervention period

• Protocol adherence rate

  Throughout the 3-week intervention period

Study Arms (1)

taVNS Paired Oromotor Training

EXPERIMENTAL

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

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Behavioral: Oral Sensorimotor Training Protocol

Interventions

Oral Sensorimotor Training Protocol BEHAVIORAL

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

taVNS Paired Oromotor Training

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) DEVICE

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.

taVNS Paired Oromotor Training

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Zabara Foundation: collaborator

MeSH Terms

Conditions

Deglutition Disorders; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Heather C McGhee, PhD

CONTACT

7708834902; mcghee@musc.edu

Doe Jenkins, MD

CONTACT

8433642662; jenkd@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08