Combining ear nerve stimulation and brain magnetic stimulation for depression treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate a combined treatment approach for depression by using transcutaneous auricular vagus nerve stimulation (taVNS) alongside transcranial magnetic stimulation (TMS). Participants will undergo a screening session followed by six treatment days, where they will receive either taVNS, TMS, or both in a randomized order. The study is conducted in-person at the Institute of Psychiatry in Charleston, South Carolina, and targets individuals who have not responded to traditional antidepressant medications. The goal is to determine if this combined method can more effectively alleviate depressive symptoms compared to each treatment alone.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

• Medical University of South Carolina Institute of Psychiatry
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Mark George, MD — Medical University of South Carolina
• Study coordinator: Mark George
• Email: georgem@musc.edu
• Phone: 843-876-5142

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.