taVNS or TMS or Both for Depression
- Conditions
- Depression
- Interventions
- Device: Vagus Nerve StimulationDevice: Transcranial Magnetic Stimulation
- Registration Number
- NCT05725239
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Synchronized VNS and TMS Vagus Nerve Stimulation - Synchronized VNS and TMS Transcranial Magnetic Stimulation - Vagus Nerve Stimulation (VNS) only Vagus Nerve Stimulation - Transcranial Magnetic Stimulation (TMS) only Transcranial Magnetic Stimulation -
- Primary Outcome Measures
Name Time Method Change in Hamilton Depression Rating Scale Through study completion, an average of 8 weeks 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.
Change in Patient Health Questionnaire 9 Through study completion, an average of 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Number of adverse outcomes One month following conclusion of the trial 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.
Trial Locations
- Locations (1)
Medical University of South Carolina Institute of Psychiatry
🇺🇸Charleston, South Carolina, United States