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

Last updated: July 24, 2024
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Treatment

Sham

taVNS

Clinical Study ID

NCT05554172
STUDY-21-01790
  • Ages 14-22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 14-22

  • Engaged in standardized refeeding in the EWDP during the intervention (may includeindividuals with anorexia nervosa or avoidant/restrictive food intake disorder)

  • Needing to gain at least 8 lbs during the refeeding period

  • English-speaking

Exclusion

Exclusion Criteria:

  • Pregnancy

  • GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowelsyndrome, 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, oraddiction to or dependence on

  • Acute suicide risk/active suicidal ideation determined with the C-SSRS. "Yes" toquestions 1 or 2 in the Suicidal Ideation section or "Yes" to any question in theSuicidal Behavior section will be exclusionary

  • Psychiatric diagnoses of schizophrenia or bipolar disorder

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Sham
Phase:
Study Start date:
December 13, 2022
Estimated Completion Date:
October 31, 2025

Study Description

The purpose of this research study is to determine the safety and ability of a device that will stimulate the vagus nerve (taVNS), in 30 adolescents ages 14-17. This project will explore if stimulation has any effect on eating behaviors in individuals with eating disorders, such as Anorexia Nervosa. Study measurements include eating behavior and other measures of behavior. These measurements will take place before and in response to the nerve stimulation during the course of a 4-week randomized trial.

Participants are assigned to one of two conditions: 1) Vagal Nerve Stimulation (n=20; this group includes use of the vagus nerve stimulator with stimulation); and 2) Sham Stimulation (n=10; this group includes use of the vagus nerve stimulator with no stimulation). Screening to determine eligibility includes physical measurements of height and weight, interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses, and online REDCap surveys.

If eligible, participants will be scheduled for 5 study visits. Procedures will include taVNS, single item meals, check-ins during treatment in the Eating and Weight Disorders Program, and self-report questionnaires.

Clinic check-ins (3 days per week while in the clinic during the 4 week intervention) will include taVNS stimulation or sham for 30 minutes. Study Visits (4 weekly study visits lasting 1 hour each) will include a single item meal test, self-report surveys, and adverse event assessment and documentation. The follow-up visit, lasting 1 hour, will take place 1 week after the final study visit and includes self-report surveys and adverse event assessment and documentation.

Connect with a study center

  • Department of Psychiatry, Eating and Weight Disorders Program

    New York, New York 10029
    United States

    Active - Recruiting

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