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

Icahn School of Medicine at Mount Sinai30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Anorexia Nervosa

Interventions

taVNSDEVICE

Participants will receive vagal nerve stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.

ShamDEVICE

Participants will receive sham stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Satisfaction Rating Scale

Treatment satisfaction will be measured using a 10-point rating scale at the follow-up visit, with range from 0 to 10. A higher score will indicate higher level of satisfaction.

Time frame: 4 weeks

Secondary Outcomes

Percent of participants with treatment-related adverse events

Safety will be measured by documenting treatment-related adverse events during the 4 weeks of treatment. Occurrences will be reported according to % of participants experiencing a treatment-related adverse event.

Time frame: 4 weeks

Dropout Rate

Tolerability of treatment will be measured using dropout rates. The drop out rate will be reported according to % of participants dropping before the completion of the follow-up visit.

Time frame: 4 weeks

Total calories consumed

Autonomous eating will be measured in total calories consumed during 4 study visits. Total calories consumed will be calculated between study visit 1 and study visit 4.

Time frame: up to 4 weeks

Change in weight from baseline to 4 weeks

Weight will be measured in the EWDP IP clinic by study staff during all study visits. Change in weight will be calculated using the baseline and 4-week measurements.

Time frame: baseline and week 4

Change in the Clinical Impairment Assessment (CIA)

Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 4-week scores from CIA.

Central Contacts

Tom Hildebrandt, PsyD

CONTACT

212-659-8673 tom.hildebrandt@mssm.edu

Jessica Bibeau, MA

CONTACT

212-659-8724 jessica.bibeau@mssm.edu

Data from ClinicalTrials.gov

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Time frame: baseline and week 4

Change in the Eating Disorder Examination (EDE-Q)

Change in eating disorder symptoms will be measured using the EDE-Q, which is a 28-item self-report measure assessing eating disorder symptoms. Each subscale (Restraint, Eating Concern, Shape Concern and Weight Concern) is scored 0-6. A global score (total scale from 0-6) is calculated by summing 4 subscales and then dividing by 4. A score of 4 or higher is considered clinically significant. Change in EDE-Q global score will be calculated using the baseline and 4-week scores.

Time frame: baseline and week 4

Change the Center for Epidemiological Studies Depression Scale (CESD)

Change in depression will be measured using the CESD, which is a 20-item self-report measure evaluating depressive symptoms. Total scores from 0 to 60. A higher score indicates higher levels of depressive symptoms. Change in CESD score will be calculated using the baseline and 4-week scores.

Time frame: baseline and week 4

Change the Anxiety Sensitivity Index (ASI)

Change in anxiety will be measured using the ASI, which is an 18-item self-report measure used to assess anxiety sensitivity. Total scores from 0-48. A higher score indicates more impairment. Change in ASI total score will be calculated using the baseline and 4-week scores.

Time frame: baseline and week 4

Change in the Visceral Sensitivity Index (VSI)

Changes in gastrointestinal-specific anxiety will be measured using the VSI, which is a 15-item measure. Total scores range from 0 (no GI-specific anxiety) to 75 (severe GI-specific anxiety). Higher scores indicate greater GI-specific anxiety. Change in VSI total score will be calculated using the baseline and 4-week scores.

Time frame: baseline and week 4

Change in hunger using a Visual Analogue Scale (VAS)

Change in hunger will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater hunger. Change in hunger will be calculated using the baseline and 4-week ratings.