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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Vagal Nerve Stimulation (taVNS)

taVNS stimulation administered during intervention

Group Type EXPERIMENTAL

taVNS

Intervention Type 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.

Sham Stimulation (Sham)

Sham stimulation administered during intervention

Group Type SHAM_COMPARATOR

Sham

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No