RECRUITING

Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression

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 study will identify the sex-dependent impact of expiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and associated physiology in major depressive disorder (MDD). We will evaluate a sample of 80 adults with recurrent MDD randomized to receive active or sham expiratory-gated tVNS during a functional magnetic resonance imaging (fMRI) session, with simultaneous mood and physiological assessments. We hypothesize that expiratory-gated tVNS will effectively modulate, in a sex-dependent manner, specific brainstem-cortical pathways of the stress circuitry and attenuate physiological deficits in MDD.

Official Title

Sex-Dependent Impact of Transcutaneous Vagal Nerve Stimulation on the Stress Response Circuitry and Autonomic Dysregulation in Major Depression

Quick Facts

Study Start:2021-01-29
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04448327

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:50 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current or past diagnosis of recurrent Major Depressive Disorder
  1. * History of neuroleptic use
  2. * Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar I disorder)
  3. * Active suicidal ideation with intent and/or plan or history of a suicide attempt within the last year
  4. * Moderate or severe substance use disorder within the past 12 months
  5. * Diagnosis of significant cardiovascular or cerebrovascular disease (e.g. congestive heart failure, stroke, cardiac conduction disorders, history of asystole or non-sustained ventricular tachycardia)
  6. * Diseases affecting the CNS (e.g. MS, epilepsy, neurodegenerative diseases, etc.)
  7. * Traumatic brain injury with cognitive sequelae
  8. * MRI or tVNS contraindications (e.g. claustrophobia, metallic implants or devices)
  9. * Pregnancy (uncommon, given the age of this cohort is 50+ years) due to unknown health risks for the fetus

Contacts and Locations

Study Contact

Ronald G Garcia, MD, PhD
CONTACT
617-643-4265
rgarciagomez@mgh.harvard.edu
Vitaly Napadow, PhD
CONTACT
617-724-3402
vitaly@mgh.harvard.edu

Principal Investigator

Ronald G Garcia, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Charlestown, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Ronald G Garcia, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2021-01-29
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-01-29
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Autonomic Nervous System
  • Transcutaneous Vagus Nerve Stimulation
  • Stress Response Circuitry
  • Functional Magnetic Resonance Imaging
  • Sex Differences

Additional Relevant MeSH Terms

  • Major Depressive Disorder