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This is a research study to find out if mental health symptoms in patients admitted to the Institute of Psychiatry are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will receive ear stimulation during their inpatient treatment at the Institute of Psychiatry. Participants will be randomly assigned to either receive ear stimulation for 1 day (up to 9 treatments over the course of a single day) or 3 days (up to 3 treatments per day), and will have a 50:50 chance of being in either group (like the flip of a coin). Each treatment will last up to 30 minutes and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. In addition, there are several questionnaires that will be completed daily while participants are receiving ear stimulation. Participants in the 1 day stimulation group will also receive 2 days of follow up questionnaires after the initial day of stimulation. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep. The ear stimulation treatments will not interfere with the care subjects are receiving from the medical team. In order to qualify for this study, participants must be actively receiving inpatient care at the MUSC Institute of Psychiatry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcutaneous auricular neurostimulation (low dose) | Experimental | All taVNS procedures will be conducted using the Spark Biomedical device. Electrodes will be placed on the left auricle and we will use stimulation parameters similar to ongoing taVNS work (25Hz, 500us pulse width) and a duty cycle of 1 minute on, 30 s off, repeated for 30 minutes. The low dose taVNS group will receive up to 3 treatments per day over the course of 3 days (for a total of up to 9 treatments). |
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| transcutaneous auricular neurostimulation (high dose) | Experimental | All taVNS procedures will be conducted using the Spark Biomedical device. Electrodes will be placed on the left auricle and we will use stimulation parameters similar to ongoing taVNS work (25Hz, 500us pulse width) and a duty cycle of 1 minute on, 30 s off, repeated for 30 minutes. The high dose taVNS group will receive up to 9 treatments in a single day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular neurostimulation | Device | All transcutaneous auricular neurostimulation procedures will be conducted using the Spark Biomedical device. We will use stimulation parameters similar to ongoing taVNS work (25Hz, 500us pulse width) and a duty cycle of 1 minute on, 30 s off, repeated for 30 minutes. taVNS sessions are considered complete after 30minutes. Subsequent taVNS sessions may be repeated no less than 30minutes after prior session completion. All subjects will begin with taVNS administered to the left auricle, however, if they begin to experience any irritation or discomfort of the left ear, study team staff will offer subjects the option to stop stimulation or switch stimulation to the right auricle. |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effect and Adverse Event Report | Subjects will be monitored for adverse effects while receiving treatments. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| General Anxiety Disorder-7 (GAD-7) Scale | Subjects will conduct pre- and post- anxiety assessments to understand if stimulation improves neuropsychiatric condition. Higher GAD-7 scores indicate higher anxiety symptoms. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40117415 | Derived | Austelle CW, Cox SS, Connolly DJ, Baker Vogel B, Peng X, Wills K, Sutton F, Tucker KB, Ashley E, Manett A, Cortese B, Short EB, Badran BW. Accelerated Transcutaneous Auricular Vagus Nerve Stimulation for Inpatient Depression and Anxiety: The iWAVE Open Label Pilot Trial. Neuromodulation. 2025 Jun;28(4):672-681. doi: 10.1016/j.neurom.2025.02.003. Epub 2025 Mar 19. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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