Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Anorexia Nervosa
In brief
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.
Key facts
- Study ID
- NCT05554172
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 30
- Starts
- 2022-12-13
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-10-07
Who can join
Age: 14 and older, up to 22. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department of Psychiatry, Eating and Weight Disorders Program — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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