COMPLETED

Mastoid taVNS-fMRI

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

The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. Investigators will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.

Official Title

Investigating the Direct Brain Effects of Activating the Auricular Branch of the Vagus Nerve From the Cymba Concha or Mastoid Process: a Sham-controlled fMRI Study

Quick Facts

Study Start:2024-08-26
Study Completion:2025-04-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06518356

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-65
  2. * Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
  1. * Unable to speak in English.
  2. * Contraindicated for MRI.
  3. * Any current or recent untreated medical, neurological, or psychiatric conditions
  4. * Metal implant devices in the head, heart or neck.
  5. * History of brain surgery.
  6. * History of myocardial infarction or arrhythmia, bradycardia.
  7. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
  8. * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  9. * Participant has abnormal ear anatomy, skin irritation, or ear infection present
  10. * Individuals suffering from frequent/severe headaches.
  11. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
  12. * Moderate to severe alcohol or substance use disorder.
  13. * Pregnancy

Contacts and Locations

Principal Investigator

Xiaolong Peng
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina Institute of Psychiatry
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Xiaolong Peng, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Date2024-08-26
Study Completion Date2025-04-28

Study Record Updates

Study Start Date2024-08-26
Study Completion Date2025-04-28

Terms related to this study

Keywords Provided by Researchers

  • Healthy Volunteer Studies

Additional Relevant MeSH Terms

  • Auricular Stimulation