RECRUITING

taVNS or TMS or Both for Depression

Conditions

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 the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.

Official Title

Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)

Quick Facts

Study Start:2023-03-14
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05725239

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 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-75 years old
  2. * Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode
  3. * Able to provide informed consent
  4. * English speaking and can read and write
  5. * 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20
  6. * Not responding to talking therapy.
  1. * Preexisting neurological disorders, or dementia
  2. * History of major head trauma
  3. * Life expectancy \<1 year
  4. * Any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation
  5. * A score of \>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality
  6. * Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded
  7. * Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.

Contacts and Locations

Study Contact

Mark George
CONTACT
843-876-5142
georgem@musc.edu

Principal Investigator

Mark George, MD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina Institute of Psychiatry
Charleston, South Carolina, 29412
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Mark George, MD, 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 Date2023-03-14
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Depression