taVNS on the Inpatient Psychiatric Unit

NCT ID: NCT05791383

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-03-24

Brief Summary

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

transcutaneous auricular neurostimulation (low dose)

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).

Group Type: EXPERIMENTAL

transcutaneous auricular neurostimulation

Intervention Type: 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.

transcutaneous auricular neurostimulation (high dose)

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.

Group Type: EXPERIMENTAL

transcutaneous auricular neurostimulation

Intervention Type: 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.

Interventions

transcutaneous auricular neurostimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 18 and up
• English speaking
• Admitted to 3 North's inpatient unit in MUSC's Institute of Psychiatry (IOP)
• Have the capacity and ability to provide one's own consent and sign the informed consent document
• Primary depression diagnosis

Exclusion Criteria

• Facial or ear pain or recent ear trauma.
• Metal implant devices in the head, heart or neck.
• History of brain surgery.
• History of myocardial infarction or arrhythmia, bradycardia.
• Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms.
• Active GI symptoms with a history of diabetes mellitus or history of gastroparesis secondary to diabetes mellitus.
• Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
• Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
• Individuals suffering from frequent/severe headaches.
• Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
• Individuals who are catatonic or otherwise unable to participate in the informed consent process.
• Moderate to severe alcohol or substance use disorder.
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Peng

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40117415 (View on PubMed)

Other Identifiers

00120876

Identifier Type: -

Identifier Source: org_study_id