Tests two nerve and brain stimulation methods for treatment-resistant depression
Tests ear nerve stimulation and magnetic brain stimulation, alone or together, in adults with depression.
Plain-language title generated from the registry record
Registry title: taVNS or TMS or Both for Depression
Key facts
- Where
- Charleston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05725239, who can take part
Where in United States
- Medical University of South Carolina Institute of PsychiatryCharleston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of South Carolina
- Trial code
- NCT05725239
- Record updated
- 12 August 2026
- Original 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.Read full original descriptionShow less
Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)
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.
Inclusion: 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: 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; Preexisting neurological disorders, or dementia; History of major head trauma; Any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation; Life expectancy <1 year; A score of >2 on question 3 of the Hamilton Depression Rating pertaining to suicidality; Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.