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NCT Number: NCT05554172

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

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

14 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Eating and Weight Disorders Program

New York, 10029, United States

Location status: Recruiting

Location contact

Jessica Bibeau, MA

CONTACT

[email protected]

212-659-8724

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

taVNS

Device

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.

SHAM

Device

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.

Primary outcomes

  1. Satisfaction Rating Scale

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Percent of participants with treatment-related adverse events

    Time frame: 4 weeks

    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.

  2. Dropout Rate

    Time frame: 4 weeks

    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.

  3. Total calories consumed

    Time frame: up to 4 weeks

    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.

  4. Change in weight from baseline to 4 weeks

    Time frame: baseline and week 4

    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.

  5. Change in the Clinical Impairment Assessment (CIA)

    Time frame: baseline and week 4

    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.

  6. Change in the Eating Disorder Examination (EDE-Q)

    Time frame: baseline and week 4

    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.

  7. Change the Center for Epidemiological Studies Depression Scale (CESD)

    Time frame: baseline and week 4

    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.

  8. Change the Anxiety Sensitivity Index (ASI)

    Time frame: baseline and week 4

    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.

  9. Change in the Visceral Sensitivity Index (VSI)

    Time frame: baseline and week 4

    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.

  10. Change in hunger using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

    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.

  11. Change in fullness using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  12. Change in sickness using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  13. Change in control using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  14. Change in urge to eat using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  15. Change in thoughts of food using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  16. Change in disgust using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  17. Change in fear using a Visual Analogue Scale (VAS)

    Time frame: baseline and 4 weeks

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

  18. Change in the Gastroparesis Cardinal Symptom Index (GCSI)

    Time frame: baseline and 4 weeks

    Change in gastroparesis will be measured using the GCSI, which is a 6-item measure. Full scale from 0-5. Higher scores indicate more discomfort. Change in GCSI total score will be calculated using the baseline and 4-week scores.

  19. Change in the Disgust Scale-Revised (DS-R)

    Time frame: baseline and 4 weeks

    Change in disgust will be measured using the DS-R, which is a 27-item measure assessing degree of disgust associated with food. Scores range from 0 - 100 and higher scores indicate a higher level of disgust. Change in DS-R total score will be calculated using the baseline and 4-week scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Bibeau, MA

CONTACT

[email protected]

212-659-8724

Tom Hildebrandt, PsyD

CONTACT

[email protected]

212-659-8673

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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