Icahn School of Medicine at Mount Sinai
Tom Hildebrandt
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
Anorexia Nervosa
taVNS
Sham
Not Applicable
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 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, United States, 10029