RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-12-13
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05554172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 14-22
  2. * Engaged in standardized refeeding in the EWDP during the intervention (may include individuals with anorexia nervosa or avoidant/restrictive food intake disorder)
  3. * Needing to gain at least 8 lbs during the refeeding period
  4. * English-speaking
  1. * Pregnancy
  2. * GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known GI obstruction)
  3. * GI surgery in the last 3 months
  4. * Implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump
  5. * Allergies to the ingredients in the shake provided
  6. * Use of illicit substances including misuse, overuse, abuse, illegal use, or addiction to or dependence on
  7. * 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
  8. * Psychiatric diagnoses of schizophrenia or bipolar disorder

Contacts and Locations

Study Contact

Tom Hildebrandt, PsyD
CONTACT
212-659-8673
tom.hildebrandt@mssm.edu
Jessica Bibeau, MA
CONTACT
212-659-8724
jessica.bibeau@mssm.edu

Principal Investigator

Tom Hildebrandt, PsyD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Tom Hildebrandt, PsyD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Anorexia Nervosa