Recruiting

taVNS & TMStaVNS or TMS or Both for Depression

Sponsor:

Medical University of South Carolina

Code:

NCT05725239

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vagus Nerve Stimulation

Transcranial Magnetic Stimulation

Study Details

Brief summary:

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.

Conditions

Depression

Study ID

NCT05725239

Start date

Mar 14, 2023

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vagus Nerve Stimulation (VNS) only

experimental: Transcranial Magnetic Stimulation (TMS) only

experimental: Synchronized VNS and TMS

Interventions

Vagus Nerve Stimulation

All taVNS sessions will use the following parameters: 25Hz, 500us pulse width, on for 7 seconds, off for 12 seconds.The length of VNS treatment sessions will be identical to TMS treatment sessions and will have the same 30 minute break between each treatment session. These treatments (active or sham) will be administered to participants each treatment day, for a total of 6 different treatment days, but only 4 are active.

Transcranial Magnetic Stimulation

Participants will receive 20 trains of 30 pulses each for a total of 600 pulses per session. We will repeat this for 6 sessions each day, with at least 30 minutes between each session. These treatments (active or sham) will be administered to participants each treatment day, for a total of 6 different treatment days, but only 4 are active, so participants will get 24 TMS sessions over the course.

Primary outcome measure

Change in Hamilton Depression Rating Scale [ Time Frame: Through study completion, an average of 8 weeks ]
Change in Patient Health Questionnaire 9 [ Time Frame: Through study completion, an average of 8 weeks ]

Central Contacts and Locations

Central contacts

Mark George

843-876-5142 georgem@musc.edu

Locations

Medical University of South Carolina Institute of Psychiatry

Recruiting

Charleston, South Carolina, United States, 29412

Contacts

Mark George

georgem@musc.edu

Elisabeth Collins

collieli@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-12.