This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation. The aims will assess if taVNS results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation.
Ages 14-22
Engaged in standardized refeeding in the EWDP during the intervention (may include individuals with anorexia nervosa or avoidant/restrictive food intake disorder)
Needing to gain at least 8 lbs during the refeeding period
English-speaking
Pregnancy
GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known GI obstruction)
GI surgery in the last 3 months
Implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump
Parallel
taVNS
DeviceParticipants will receive vagal nerve stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.
Sham
DeviceParticipants will receive sham stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.
Satisfaction Rating Scale
Treatment satisfaction will be measured using a 10-point rating scale at the follow-up visit, with range from 0 to 10. A higher score will indicate higher level of satisfaction.
Percent of participants with treatment-related adverse events
Safety will be measured by documenting treatment-related adverse events during the 4 weeks of treatment. Occurrences will be reported according to % of participants experiencing a treatment-related adverse event.
Dropout Rate
Tolerability of treatment will be measured using dropout rates. The drop out rate will be reported according to % of participants dropping before the completion of the follow-up visit.
Total calories consumed
Autonomous eating will be measured in total calories consumed during 4 study visits. Total calories consumed will be calculated between study visit 1 and study visit 4.
Change in weight from baseline to 4 weeks
Weight will be measured in the EWDP IP clinic by study staff during all study visits. Change in weight will be calculated using the baseline and 4-week measurements.
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