Learning and Ear Stimulation

Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning

This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours. Researchers will measure brain waves and other body responses (heart rate), while while the ear is stimulated. Participants also will be asked to complete computer tasks. Because brain activity will be measured, participants will be asked to come to the study with clean, dry hair. The study is at MUSC in Charleston. Participants will be compensated for their time. To be eligible, participants must be 18-65 years old, be able to commit 2.5 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer.

There are some risks to completing this study. Some questions in the surveys ask about personal thoughts and feelings. The ear stimulation may cause tingling sensations or irritation around the ear.

There are no direct benefits to participants. This study will help researchers improve this ear stimulation as a treatment method.

Study Overview

• Status: Completed
• Conditions: Learning; taVNS
• Intervention / Treatment: Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes; Device: taVNS 30 minutes; Device: taVNS 45 minutes; Device: taVNS 60 minutes; Device: taVNS 75 minutes; Device: taVNS 0 minutes

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking
• Non-treatment-seeking community members who do not have a mental health diagnosis and individuals seeking treatment for an anxiety, mood, trauma-related, or obsessive-compulsive disorder.
• Treatment and non-treatment-seeking community members with anxiety, mood, trauma-related, or obsessive-compulsive disorder or symptoms.

Exclusion Criteria:

• Diagnosis of COVID-19 in the past 14 days
• Facial or ear pain or recent ear trauma
• Metal implant devices in the head, heart or neck
• History of brain stimulation or other brain surgery
• History of myocardial infarction or arrhythmia, bradycardia
• Use of B-blockers, antiarrhythmic medication (sodium/potassium/calcium-channel blockers), or blood pressure medications.
• Active respiratory disorder
• 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 lifetime evidence of severe psychiatric disorder (e.g., schizophrenia) or neurological disorder.
• Moderate to severe alcohol or substance use disorder.
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dose Group 1	Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes; Sham 60 minutes and taVNS active stimulation for 15 minutes
Other: Dose Group 2	Device: taVNS 30 minutes; Sham 45 minutes and taVNS active stimulation for 30 minutes
Other: Dose Group 3	Device: taVNS 45 minutes; Sham 30 minutes and taVNS active stimulation for 45 minutes
Other: Dose Group 4	Device: taVNS 60 minutes; Sham 15 minutes and taVNS active stimulation for 60 minutes
Other: Dose Group 5	Device: taVNS 75 minutes; Sham 0 minutes and taVNS active stimulation for 75 minutes
Other: Dose Group 6	Device: taVNS 0 minutes; Sham taVNS 75 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in P300 Amplitude	Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.	Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes
Change in Heart Rate Variability		Baseline to end of Active Stimulation

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00107689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No