Clinical trial NCT05554172: Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Official title: Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two conditions (vagal nerve stimulation or sham stimulation) according to a ratio of 2:1. The Vagal Nerve Stimulation group includes use of the vagus nerve stimulator with stimulation and the Sham Stimulation group includes use of the vagus nerve stimulator with no stimulation. Participants will be openly-enrolled until the recruitment goal of 30 is reached.
Primary purpose: TREATMENT

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.

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 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, and online REDCap surveys.

If eligible, participants will be scheduled for 5 study visits. Procedures will include taVNS, single item meals, check-ins during treatment in the Eating and Weight Disorders Program, 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.

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

Primary outcomes:
measure: Satisfaction Rating Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent of participants with treatment-related adverse events
timeFrame: 4 weeks
measure: Dropout Rate
timeFrame: 4 weeks
measure: Total calories consumed
timeFrame: up to 4 weeks
measure: Change in weight from baseline to 4 weeks
timeFrame: baseline and week 4
measure: Change in the Clinical Impairment Assessment (CIA)
timeFrame: baseline and week 4
measure: Change in the Eating Disorder Examination (EDE-Q)
timeFrame: baseline and week 4
measure: Change the Center for Epidemiological Studies Depression Scale (CESD)
timeFrame: baseline and week 4
measure: Change the Anxiety Sensitivity Index (ASI)
timeFrame: baseline and week 4
measure: Change in the Visceral Sensitivity Index (VSI)
timeFrame: baseline and week 4
measure: Change in hunger using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in fullness using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in sickness using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in control using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in urge to eat using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in thoughts of food using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in disgust using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in fear using a Visual Analogue Scale (VAS)
timeFrame: baseline and 4 weeks
measure: Change in the Gastroparesis Cardinal Symptom Index (GCSI)
timeFrame: baseline and 4 weeks
measure: Change in the Disgust Scale-Revised (DS-R)
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Eating and Weight Disorders Program
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Tom Hildebrandt, PsyD
role: PRINCIPAL_INVESTIGATOR
References: