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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagus Nerve Stimulation (VNS) only | Experimental |
| |
| Transcranial Magnetic Stimulation (TMS) only | Experimental |
| |
| Synchronized VNS and TMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale | The Hamilton Depression Rating Scale (HDRS) is a commonly used clinician-administered depression rating scale to assess severity of depressive symptoms. The HDRS has a possible score range of 0-52. The higher the HDRS score, the more severe the depressive symptoms are in that patient. | Through study completion, an average of 8 weeks |
| Change in Patient Health Questionnaire 9 | The Patient Health Questionnaire 9 (PHQ-9) is a brief self-administered questionnaire to assess depressive symptoms. The PHQ-9 has a possible score range of 0-27. The higher the PHQ-9 score, the more severe the depressive symptoms are in that patient. | Through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse outcomes | Participants will be called at the 1 week and 1 month timepoints following their completion of the trial to inquire about any adverse outcomes they have experienced, if any, since the conclusion of the trial as a means of measuring feasibility of the treatment. | One week following conclusion of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark George | Contact | 843-876-5142 | georgem@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark George, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry | Recruiting | Charleston | South Carolina | 29412 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D055909 | Magnetic Field Therapy |
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| Transcranial Magnetic Stimulation | Device | 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. |
|
| Number of adverse outcomes |
Participants will be called at the 1 week and 1 month timepoints following their completion of the trial to inquire about any adverse outcomes they have experienced, if any, since the conclusion of the trial as a means of measuring feasibility of the treatment. |
| One month following conclusion of the trial |