Non-invasive vagus nerve stimulation for treating low weight eating disorders
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
NA · Icahn School of Medicine at Mount Sinai · NCT05554172
This study is testing whether a new type of nerve stimulation before meals can help teenagers with anorexia nervosa feel more satisfied with their meals and eat more without feeling too full.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 14 Years to 22 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05554172 on ClinicalTrials.gov |
What this trial studies
This project involves a 4-week randomized trial comparing the effects of pre-meal vagal nerve stimulation (taVNS) to sham stimulation in adolescents with anorexia nervosa. The study aims to assess whether taVNS leads to greater meal satisfaction, increased calorie intake, reduced feelings of fullness, decreased eating disorder symptoms, and lower anxiety levels compared to sham stimulation. Participants will undergo a series of assessments, including eating behavior measurements and self-report questionnaires, during five scheduled visits throughout the intervention period.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 14-22 who are engaged in standardized refeeding and need to gain at least 8 lbs during the intervention.
Not a fit: Patients with gastrointestinal disturbances, recent GI surgery, or acute suicide risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve eating behaviors and overall well-being in adolescents with anorexia nervosa.
How similar studies have performed: While the use of vagus nerve stimulation is a novel approach in this context, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Department of Psychiatry, Eating and Weight Disorders Program — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Tom Hildebrandt, PsyD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Tom Hildebrandt, PsyD
- Email: tom.hildebrandt@mssm.edu
- Phone: 212-659-8673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anorexia Nervosa