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Recruiting NCT05554172

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

Conditions: Anorexia Nervosa

Sex: All
Ages: 14 Years – 22 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Icahn School of Medicine at Mount Sinai

Location: Department of Psychiatry, Eating and Weight Disorders Program New York New York

Summary

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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05554172). StuddyBuddy aggregates publicly available trial information.