NCT05725239Recruiting
taVNS or TMS or Both for Depression
Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 18 Jan 2023
- Start date
- 14 Mar 2023
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Depression
- NCT number
- NCT05725239
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 14 Mar 2023 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.