Non-invasive vagus nerve stimulation for treating low weight eating disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project involves a 4-week randomized trial comparing the effects of pre-meal vagal nerve stimulation (taVNS) to sham stimulation in adolescents with anorexia nervosa. The study aims to assess whether taVNS leads to greater meal satisfaction, increased calorie intake, reduced feelings of fullness, decreased eating disorder symptoms, and lower anxiety levels compared to sham stimulation. Participants will undergo a series of assessments, including eating behavior measurements and self-report questionnaires, during five scheduled visits throughout the intervention period.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Psychiatry, Eating and Weight Disorders Program
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Tom Hildebrandt, PsyD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Tom Hildebrandt, PsyD
• Email: tom.hildebrandt@mssm.edu
• Phone: 212-659-8673

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Specialist Supportive Clinical Management for teens with anorexia or atypical anorexia

  This study tests a teen-focused SSCM approach to help 13-17 year-olds with anorexia nervosa or atypical anorexia nervosa when other treatments haven’t worked or can’t be used.

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• Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa

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• Online FBT-DBT for Caregivers of Teens with Anorexia Nervosa

  This online program tests a combination of family-based and DBT skills to help caregivers of teens with anorexia nervosa manage stress and improve family support.

  Recruiting Shanghai Mental Health Center · Shanghai · NCT07734779

• Eating Disorder Dynamic Intervention

  A digital program is tested to help adults with eating disorders by sending real-time, personalized coping tips based on smartphone surveys and sensor data.

  Recruiting Trustees of Dartmouth College · Lebanon, New Hampshire · NCT07600671

• Hormone and metabolic patterns in hypothalamus-like brain cells from people with anorexia nervosa

  This study will test whether hypothalamic-like neurons made from adult women with long-standing anorexia nervosa respond differently to metabolic hormones than neurons from healthy women.

  Recruiting University of Zurich · Zurich · NCT07580209

• Narrative medicine workshops to support teens and young adults with anorexia nervosa (virtual)

  This program tests whether a six-week series of narrative medicine workshops can help 16–25-year-olds with anorexia nervosa express themselves, reflect, and build resilience.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07579442

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.