Home › Anorexia Nervosa › NCT05554172
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Recruiting
Who can join
Ages 14 to 22 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- taVNS (device)
- Sham (device)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 30 · Started: Dec 13, 2022
Contact the study team
- Tom Hildebrandt, PsyD · Phone: 212-659-8673
- Jessica Bibeau, MA · Phone: 212-659-8724
Official record on ClinicalTrials.gov — NCT05554172
Locations in the U.S.
| New York | Department of Psychiatry, Eating and Weight Disorders Program, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.