Dysphagia, Feeding and Eating Disorders of Infancy, Swallowing Disorders
Conditions
Keywords
Transcutaneous Auricular Vagus Nerve Stimulation, Oromotor Training, Dysphagia, Feeding Disorders
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.
Interventions
DEVICETranscutaneous 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.
BEHAVIORALOral 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.
Sponsors
Medical University of South Carolina
Zabara Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallowing impairment as measured by the BaByVFSImP | Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period | 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. |
| Change in airway protection as measured by the Penetration-Aspiration Scale | Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period | 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. |
| Change in early feeding skills as measured by the Early Feeding Skills Assessment | Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period | 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. |
| Change in sucking pressures | Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period | Sucking pressures will be measured. Values will be compared from pre-treatment to post-treatment to evaluate change in sucking mechanics. |
| Change in oral feeding volume | Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of bradycardia events during intervention | During each intervention session throughout the 3-week intervention period | Safety will be assessed by recording the number of bradycardia events occurring during intervention sessions. Bradycardia will be defined as heart rate less than 80 beats per minute for 5 seconds or longer during a feed. Events will be recorded per feeding session. |
| Number of oxygen desaturation events during intervention | During each intervention session throughout the 3-week intervention period | Safety will be assessed by recording the number of oxygen desaturation events occurring during intervention sessions. Oxygen desaturation will be defined as oxygen saturation less than 80% for 5 seconds or longer during a feed. Events will be recorded per feeding session. |
| Number of coughing or choking episodes during intervention | During each intervention session throughout the 3-week intervention period | Safety will be assessed by recording the number of coughing or choking episodes occurring during intervention sessions. Events will be recorded per feeding session to monitor clinical signs of feeding intolerance or airway compromise. |
| Intervention completion rate | End of the 3-week intervention period | Feasibility will be assessed by determining the number and percentage of enrolled infants who complete the full 3-week paired taVNS and oromotor training intervention. Completion will be defined as finishing the planned intervention period. |
| Protocol adherence rate | Throughout the 3-week intervention period | Feasibility will be assessed by recording the number and percentage of planned oromotor training sessions completed. Protocol adherence will be calculated as the number of completed sessions divided by the number of planned sessions. |
| Oromotor treatment tolerance measured by adverse event rate per session | During each 30-minute intervention session throughout the 3-week intervention period | Treatment tolerance will be assessed using an events-to-time ratio, calculated as the number of bradycardia and/or oxygen desaturation events occurring during each 30-minute oromotor training session. A lower event rate indicates better treatment tolerance. |
Contacts
CONTACTHeather C McGhee, PhD
CONTACTDoe Jenkins, MD
Outcome results
None listed