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Not Yet Recruiting NCT05725239

taVNS or TMS or Both for Depression

Conditions: Depression

Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 24
Sponsor: Medical University of South Carolina

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 Criteria

Inclusion Criteria:18-75 years oldUndergoing cervical VNS or have tried and failed two antidepressant medications in the current episodeAble to provide informed consentEnglish speaking and can read and write17-item Hamilton Depression Rating Scale (HAM-D) score ≥20Not responding to talking therapy.Exclusion Criteria:Preexisting neurological disorders, or dementiaHistory of major head traumaLife expectancy <1 yearAny type of cognitive impairment that would require approval/signature of a legal guardian/representative for participationA score of >2 on question 3 of the Hamilton Depression Rating pertaining to suicidalityCurrent 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 excludedPatients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05725239). StuddyBuddy aggregates publicly available trial information.