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taVNS or TMS or Both for Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether stimulating a nerve in the ear and using magnets to stimulate the brain work better together for depression than either treatment alone. It is for adults with depression who already use a neck nerve stimulation device or have tried two antidepressants that did not work. It includes an in-person screening and 6 treatment days in downtown Charleston; people with a neck device will use it instead of ear stimulation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 75 years old.
  • Use a vagus nerve stimulation (VNS) device in the neck, or have tried two antidepressants that did not work during your current period of depression.
  • Can understand the study and agree to take part.
  • Speak English and can read and write.
  • Score 20 or higher on the 17-question Hamilton Depression Rating Scale, which measures depression symptoms.
  • Have not improved with talk therapy.

Who can't join

  • Have a disorder of the brain or nerves, or dementia, which affects memory and thinking.
  • Have had a major head injury.
  • Are expected to live less than 1 year.
  • Have thinking or memory problems that mean a legal guardian or representative must approve your participation.
  • Score above 2 on the Hamilton Depression Rating Scale question about suicide.
  • Currently intend or plan to attempt suicide, have attempted suicide in the past 6 months, or are judged by the study doctor to have a higher suicide risk.
  • Are pregnant. People who could become pregnant must take a pregnancy test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

SC