Vagus Nerve Stimulation for Eating Disorders

This study is looking at whether a device that stimulates the vagus nerve (taVNS) can help young people with Anorexia Nervosa. Researchers want to see if taVNS, compared to a sham (fake) stimulation, leads to greater satisfaction with eating, more calorie intake, less feeling of fullness, fewer eating disorder symptoms, and less anxiety. You might be able to join if you are 14-22 years old, are already in a program to gain weight for an eating disorder, need to gain at least 8 pounds, and speak English. The study aims to enroll 30 participants and will measure satisfaction after 4 weeks.

Study design
This is a randomized study with 30 participants, comparing two groups: one receiving vagal nerve stimulation and another receiving sham (fake) stimulation.
What's involved
You would have 5 study visits, including single item meals and check-ins during your eating disorder treatment. You would receive stimulation or sham treatment for 30 minutes, 3 days a week for 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, satisfaction, is measured at 4 weeks, which is the duration of the intervention.

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NCT05554172

Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders

Recruiting
NAAges 14–22InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~30 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:taVNSSham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Satisfaction Rating Scale
Measured over 4 weeks
Anorexia Nervosa
1 sites across 1 states
New York1
  • Tom Hildebrandt, PsyD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

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
  • Satisfaction Rating Scale4 weeks

    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.