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taVNS or TMS or Both for Depression

This study is testing a new way to treat depression by combining two types of brain stimulation: transcutaneous auricular vagus nerve stimulation (taVNS), which stimulates a nerve in the ear, and transcranial magnetic stimulation (TMS), which uses magnets to stimulate the brain. Researchers believe this combined approach might work better than either treatment alone. You might be able to join if you are 18-75 years old, have depression, and have not responded to talking therapy or at least two antidepressant medications. If you already have a cervical VNS device, it will be used instead of taVNS. The study will measure changes in your depression symptoms using two common scales (Hamilton Depression Rating Scale and Patient Health Questionnaire 9) over about 8 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 24 participants. It is testing the effects of taVNS, TMS, or both interventions.
What's involved
Participants will receive 6 sessions of TMS (active or sham) each day, with at least 30 minutes between sessions. taVNS sessions will be the same length as TMS sessions, also with a 30-minute break between each.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured through study completion, which is an average of 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05725239

taVNS or TMS or Both for Depression

Recruiting
NAAges 18–75InterventionalTreatment
Medical University of South Carolina
~24 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Vagus Nerve StimulationTranscranial Magnetic Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hamilton Depression Rating Scale
Measured over Through study completion, an average of 8 weeks
+1 more outcome measured

Conditions

Depression

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NCT05725239

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Medical University of South Carolina Institute of Psychiatry

    Charleston, South Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mark George, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Mark George
[email protected]
843-876-5142
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Change in Hamilton Depression Rating ScaleThrough study completion, an average of 8 weeks

    The Hamilton Depression Rating Scale (HDRS) is a commonly used clinician-administered depression rating scale to assess severity of depressive symptoms. The HDRS has a possible score range of 0-52. The higher the HDRS score, the more severe the depressive symptoms are in that patient.

  • Change in Patient Health Questionnaire 9Through study completion, an average of 8 weeks

    The Patient Health Questionnaire 9 (PHQ-9) is a brief self-administered questionnaire to assess depressive symptoms. The PHQ-9 has a possible score range of 0-27. The higher the PHQ-9 score, the more severe the depressive symptoms are in that patient.