Actively Recruiting

Phase Not Applicable
Age: 14Years - 22Years
All Genders
NCT05554172

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-10-07

30

Participants Needed

1

Research Sites

198 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 14Years - 22Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 14 to 22 years
  • Currently engaged in standardized refeeding in the Eating and Weight Disorder Intensive Program
  • Need to gain at least 8 pounds during the refeeding period
  • English-speaking
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Gastrointestinal disorders such as Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or known/suspected GI obstruction
  • Gastrointestinal surgery within the last 3 months
  • Implanted or portable electro-mechanical devices like pacemakers, defibrillators, or infusion pumps
  • Allergic to ingredients in the provided shake
  • Use of illicit substances including misuse or addiction
  • Acute suicide risk or active suicidal thoughts as determined by C-SSRS
  • Diagnosis of schizophrenia or bipolar disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, United States, 10029

Actively Recruiting

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Research Team

T

Tom Hildebrandt, PsyD

CONTACT

J

Jessica Bibeau, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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