taVNS on the Inpatient Psychiatric Unit

NCT05791383 | Completed FDA Device

• 1 other identifier: 00120876
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Side Effect and Adverse Event Report

  Subjects will be monitored for adverse effects while receiving treatments.

  4 days

Secondary Outcomes (1)

• General Anxiety Disorder-7 (GAD-7) Scale

  4 days

Study Arms (2)

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).

Device: transcutaneous auricular neurostimulation

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.

Device: transcutaneous auricular neurostimulation

Interventions

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.

transcutaneous auricular neurostimulation (high dose); transcutaneous auricular neurostimulation (low dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 40117415 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: March 30, 2023
• Study Start: December 1, 2022
• Primary Completion: March 24, 2024
• Study Completion: March 24, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)