Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05725239

taVNS or TMS or Both for Depression

Led by Medical University of South Carolina · Updated on 2025-08-05

24

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

taVNS or TMS or Both for Depression

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Currently undergoing cervical VNS or have tried and failed two antidepressant medications in the current depressive episode
  • Able to provide informed consent
  • Able to read, write, and speak English
  • Hamilton Depression Rating Scale (17-item) score of at least 20
  • Not responding to talking therapy for depression
Not Eligible

You will not qualify if you...

  • Preexisting neurological disorders or dementia
  • History of major head trauma
  • Life expectancy less than 1 year
  • Cognitive impairment requiring legal guardian approval
  • Score above 2 on suicidality question of Hamilton Depression Rating Scale
  • Active suicidal intent or plan, recent suicide attempt within 6 months, or judged at high suicide risk
  • Pregnancy or potential for pregnancy without confirmed negative pregnancy test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, United States, 29412

Actively Recruiting

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Research Team

M

Mark George

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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