RecruitingNot ApplicableNCT05725239

taVNS or TMS or Both for Depression

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

Sponsor

Medical University of South Carolina

Enrollment

24 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

Depression

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three types of brain stimulation treatments for depression: ear nerve stimulation (taVNS), transcranial magnetic stimulation (TMS), or a combination of both. It targets people with treatment-resistant depression who have not responded to medication. **You may be eligible if...** - You are 18–75 years old - You speak English and can read and write - You have moderate to severe depression that has not responded to at least two antidepressant medications, OR you are already receiving vagus nerve stimulation (VNS) - Your depression score on a standard scale (HAM-D) is 20 or higher **You may NOT be eligible if...** - You have metal implants in your head or certain medical devices - You have a history of seizures - You are currently at high risk for suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVagus 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.

DEVICETranscranial 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.