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OpenTrials
Completed

NCT Number: NCT04812015

Learning and Ear Stimulation

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.

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Key information

Conditions

Learning taVNS

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes

Device

Sham 60 minutes and taVNS active stimulation for 15 minutes

taVNS 30 minutes

Device

Sham 45 minutes and taVNS active stimulation for 30 minutes

taVNS 45 minutes

Device

Sham 30 minutes and taVNS active stimulation for 45 minutes

taVNS 60 minutes

Device

Sham 15 minutes and taVNS active stimulation for 60 minutes

taVNS 75 minutes

Device

Sham 0 minutes and taVNS active stimulation for 75 minutes

taVNS 0 minutes

Device

Sham taVNS 75 minutes

Primary outcomes

  1. Change in P300 Amplitude

    Time frame: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes

    Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.

  2. Change in Heart Rate Variability

    Time frame: Baseline to end of Active Stimulation

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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