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

Mount Sinai Health System

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Device: Sham; Device: taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT05554172

STUDY-21-01790

Details and patient eligibility

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 14 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Vagal Nerve Stimulation (taVNS)

Experimental group

Description:

taVNS stimulation administered during intervention

Treatment:

Device: taVNS

Sham Stimulation (Sham)

Sham Comparator group

Description:

Sham stimulation administered during intervention

Treatment:

Device: Sham