NCT05554172 · Icahn School of Medicine at Mount Sinai
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
What this study is about
This project includes a 4-week randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
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.
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.
Primary outcome measures
Satisfaction Rating Scale
Time frame: 4 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2025 · Source of record for eligibility and locations