taVNS or TMS or Both for Depression

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.

Conditions

Depression

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Study Overview

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Study Details

Study overview

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.

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

taVNS or TMS or Both for Depression

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

Charleston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18-75 years old
  • * Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode
  • * Able to provide informed consent
  • * English speaking and can read and write
  • * 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20
  • * Not responding to talking therapy.
  • * Preexisting neurological disorders, or dementia
  • * History of major head trauma
  • * Life expectancy \<1 year
  • * Any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation
  • * A score of \>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality
  • * 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
  • * Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Mark George, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2025-07-01