taVNS or TMS or Both for Depression

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Depression

Treatments: Device: Vagus Nerve Stimulation; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05725239

00125468

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Vagus Nerve Stimulation (VNS) only

Experimental group

Treatment:

Device: Vagus Nerve Stimulation

Transcranial Magnetic Stimulation (TMS) only

Experimental group

Treatment:

Device: Transcranial Magnetic Stimulation

Synchronized VNS and TMS

Experimental group

Treatment:

Device: Transcranial Magnetic Stimulation

Device: Vagus Nerve Stimulation