Frontlight ResearchEarly access
Taking people in United StatesNo phase
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 13 Dec 2022
- Expected to end
- Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- taVNS
- Sham
- Record updated
- 8 September 2026
Who can take part
- Age
- 14 years to 22 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- GI surgery in the last 3 months
- GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known GI obstruction)
- Allergies to the ingredients in the shake provided
- Psychiatric diagnoses of schizophrenia or bipolar disorder
- Pregnancy
- Implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 22 years old?
Where in United States
- Department of Psychiatry, Eating and Weight Disorders ProgramNew York, United StatesContact: Jessica Bibeau, MATaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Vagal Nerve Stimulation (taVNS)Treatment being tested
taVNS stimulation administered during intervention
Treatment: taVNS
- Sham Stimulation (Sham)Sham treatment, for comparison
Sham stimulation administered during intervention
Treatment: Sham
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT05554172, who can take part
- Record updated
- 8 September 2026