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NCT05554172 | Recruiting | Anorexia Nervosa


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

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Tom Hildebrandt

Brief 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. Gastric parameters (rhythm, motility, and pH level) will also be measured to assess stimulation as a mediator of autonomous eating

Condition or disease

Anorexia Nervosa

Intervention/treatment

taVNS

Sham

Phase

Not Applicable

Detailed Description:

The purpose of this research study is to determine the safety and ability of a device that will stimulate the vagus nerve (taVNS), in 30 adolescents ages 14-17. This project will explore if stimulation has any effect on eating behaviors in individuals with eating disorders, such as Anorexia Nervosa. Study measurements include stomach activity, eating behavior and other measures of behavior. These measurements will take place before and in response to the nerve stimulation during the course of a 4-week randomized trial. Participants are assigned to one of two conditions: 1) Vagal Nerve Stimulation (n=20; this group includes use of the vagus nerve stimulator with stimulation); and 2) Sham Stimulation (n=10; this group includes use of the vagus nerve stimulator with no stimulation). Screening to determine eligibility includes physical measurements of height and weight, interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses, the Jelly Bean Test, which will assess ability to swallow the SmartPill (the assessment device used to measure gastric parameters), and online REDCap surveys. If eligible, participants will be scheduled for 6 study visits. Procedures will include taVNS, SmartPill ingestion pre- and post-intervention, single item meals, check-ins during treatment in the Eating and Weight Disorders Intensive Program (IP), and self-report questionnaires. Clinic check-ins (3 days per week while in the clinic during the 4 week intervention) will include taVNS stimulation or sham for 30 minutes. Study Visits (4 weekly study visits lasting 1 hour each) will include a single item meal test, self-report surveys, and adverse event assessment and documentation. The follow-up visit, lasting 1 hour, will take place 1 week after the final study visit and includes self-report surveys and adverse event assessment and documentation.}}

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Triple
Masking Description : Participants, assessment staff, and investigators will be blind to condition. When stimulation starts, both conditions will experience an effect from the device and participants will not be told which stimulation indicates real stimulation or sham.
Primary Purpose : Treatment
Official Title : Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Actual Study Start Date : December 13, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024
Arm Intervention/treatment

Experimental: Vagal Nerve Stimulation (taVNS)

taVNS stimulation administered during intervention

Device: taVNS

Sham Comparator: Sham Stimulation (Sham)

Sham stimulation administered during intervention

Device: Sham

Ages Eligible for Study: 14 Years to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria, which is assessed during the consent/screening visit
    • Ages 14-17
    • Engaged in standardized refeeding in the Intensive Program 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
    • An individual who meets any of the following criteria will be excluded from participation in this study
      • 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
      • Dysphagia to food or pills, swallowing disorders
      • Inability to swallow SmartPill
      • Failure of the Jelly Bean Test
      • Psychiatric diagnoses of schizophrenia or bipolar disorder

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

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

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, New York

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, United States, 10029

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