| NCT ID | NCT05725239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-03-14 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-03-14 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mark George, MD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05725239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05725239 currently recruiting?
Yes, NCT05725239 is actively recruiting participants. Contact the research team at georgem@musc.edu for enrollment information.
Where is the NCT05725239 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05725239 clinical trial?
NCT05725239 is sponsored by Medical University of South Carolina. The principal investigator is Mark George, MD at Medical University of South Carolina. The trial plans to enroll 24 participants.
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