RECRUITING

RM1 Project 2 - tAN 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

In this one-visit, randomized, double-blind, sham-controlled trial, we plan to use a novel concurrent transcutaneous auricular neurostimulation (tAN) paradigm during functional magnetic resonance imaging (fMRI) paradigm in 96 individuals to determine whether tAN administered to two cranial nerves simultaneously produces greater neurophysiologic effects than stimulating solely to the auricular branch of the vagus nerve (ABVN) or the auriculotemporal nerve (ATN; branch of trigeminal nerve) alone. Within the MRI scanner, each participant will be connected to a series of electrodes that stimulate 4 targets (ABVN only, ATN only, ABVN plus ATN, and Sham).

Official Title

Determining the Independent and Synergistic Effects of Transcutaneous Auricular Neurostimulation (tAN) on Direct Brain Activation in Healthy Individuals

Quick Facts

Study Start:2023-03-17
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05487664

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 and sign the informed consent document
  1. * Contraindicated for MRI.
  2. * Any current or recent untreated medical, neurological, or psychiatric conditions
  3. * Metal implant devices in the head, heart or neck.
  4. * History of brain surgery.
  5. * History of myocardial infarction or arrhythmia, bradycardia.
  6. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
  7. * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  8. * Individuals suffering from frequent/severe headaches.
  9. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
  10. * Moderate to severe alcohol or substance use disorder.
  11. * Pregnancy

Contacts and Locations

Study Contact

Bashar Badran, PhD
CONTACT
843-792-6076
badran@musc.edu

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

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 Date2023-03-17
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2023-03-17
Study Completion Date2027-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Auricular Stimulation