Anxiety & Depression Association of America

taVNS or TMS or Both for Depression

Purpose

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.

Condition

Depression

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Vagus Nerve Stimulation (VNS) only		Device: 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.
Experimental Transcranial Magnetic Stimulation (TMS) only		Device: 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.
Experimental Synchronized VNS and TMS		Device: 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. Device: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Medical University of South Carolina

Study Contact

Mark George
843-876-5142
georgem@musc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.