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

Anorexia Nervosa Clinical Trial

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

Status Recruiting

Clinical Trial 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. Gastric parameters (rhythm, motility, and pH level) will also be measured to assess stimulation as a mediator of autonomous eating

Clinical Trial 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 stomach activity, 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, the Jelly Bean Test, which will assess ability to swallow the SmartPill (the assessment device used to measure gastric parameters), and online REDCap surveys.

If eligible, participants will be scheduled for 6 study visits. Procedures will include taVNS, SmartPill ingestion pre- and post-intervention, single item meals, check-ins during treatment in the Eating and Weight Disorders Intensive Program (IP), 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. ;

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Feeding and Eating Disorders

• NCT number: NCT05554172
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Tom Hildebrandt, PsyD
• Phone: 212-659-8673
• Email: tom.hildebrandt@mssm.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Completion date: October 2024