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

NCT05554172 | Recruiting DMC FDA Device

• 1 other identifier: STUDY-21-01790
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Satisfaction Rating Scale

  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.

  4 weeks

Secondary Outcomes (19)

• Percent of participants with treatment-related adverse events

  4 weeks

• Dropout Rate

  4 weeks

• Total calories consumed

  up to 4 weeks

• Change in weight from baseline to 4 weeks

  baseline and week 4

• Change in the Clinical Impairment Assessment (CIA)

  baseline and week 4

Study Arms (2)

Vagal Nerve Stimulation (taVNS)

EXPERIMENTAL

taVNS stimulation administered during intervention

Device: taVNS

Sham Stimulation (Sham)

SHAM COMPARATOR

Sham stimulation administered during intervention

Device: Sham

Interventions

taVNS DEVICE

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.

Vagal Nerve Stimulation (taVNS)

Sham DEVICE

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.

Sham Stimulation (Sham)

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Psychiatric diagnoses of schizophrenia or bipolar disorder

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10029, United States

RECRUITING

Related Publications (1)

• Andersson P, Jamshidi E, Ekman CJ, Tedroff K, Bjorkander J, Sjogren M, Lundberg J, Jokinen J, Desai Bostrom AE. Anorexia Nervosa With Comorbid Severe Depression: A Systematic Scoping Review of Brain Stimulation Treatments. J ECT. 2023 Dec 1;39(4):227-234. doi: 10.1097/YCT.0000000000000922. Epub 2023 Apr 14.

  PMID: 37053429 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Tom Hildebrandt, PsyD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Hildebrandt, PsyD

CONTACT

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

Jessica Bibeau, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, assessment staff, and investigators will be blind to condition. When stimulation starts, both conditions will experience an effect from the device and participants will not be told which stimulation indicates real stimulation or sham.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to one of two conditions (vagal nerve stimulation or sham stimulation) according to a ratio of 2:1. The Vagal Nerve Stimulation group includes use of the vagus nerve stimulator with stimulation and the Sham Stimulation group includes use of the vagus nerve stimulator with no stimulation. Participants will be openly-enrolled until the recruitment goal of 30 is reached.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: December 13, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)