Recruiting

Non-invasive Vagus Nerve Stimulation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05554172

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 14 - 22

Healthy Volunteers: Not accepted

Interventions

taVNS

Sham

Study Details

Brief 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.

Conditions

Anorexia Nervosa

Study ID

NCT05554172

Start date

Dec 13, 2022

Status verified date

Sep, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 22

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vagal Nerve Stimulation (taVNS)

taVNS stimulation administered during intervention

sham comparator: Sham Stimulation (Sham)

Sham stimulation administered during intervention

Interventions

taVNS

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.

Sham

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.

Primary outcome measure

  • Satisfaction Rating Scale [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Tom Hildebrandt, PsyD

212-659-8673tom.hildebrandt@mssm.edu

Jessica Bibeau, MA

212-659-8724jessica.bibeau@mssm.edu

Locations

Department of Psychiatry, Eating and Weight Disorders Program

Recruiting

New York, New York, United States, 10029

Contacts

Jessica Bibeau, MA

212-659-8724jessica.bibeau@mssm.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-09-08.