Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders (NCT05554172) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
United States30 participantsStarted 2022-12-13
Plain-language 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.
Who can participate
Age range14 Years – 22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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