Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Icahn School of Medicine at Mount Sinai
30 participants
Dec 13, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria8
- 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
- Allergies to the ingredients in the shake provided
- Use of illicit substances including misuse, overuse, abuse, illegal use, or addiction to or dependence on
- Acute suicide risk/active suicidal ideation determined with the C-SSRS. "Yes" to questions 1 or 2 in the Suicidal Ideation section or "Yes" to any question in the Suicidal Behavior section will be exclusionary
- Psychiatric diagnoses of schizophrenia or bipolar disorder
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Interventions
Participants 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.
Participants 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05554172