Learning and Ear Stimulation

NCT04812015 | Completed Results FDA Device

• 1 other identifier: Pro00107689
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Learning; taVNS

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

Dose Group 1

OTHER

Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes

Dose Group 2

OTHER

Device: taVNS 30 minutes

Dose Group 3

OTHER

Device: taVNS 45 minutes

Dose Group 4

OTHER

Device: taVNS 60 minutes

Dose Group 5

OTHER

Device: taVNS 75 minutes

Dose Group 6

OTHER

Device: taVNS 0 minutes

Interventions

transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes DEVICE

Sham 60 minutes and taVNS active stimulation for 15 minutes

Dose Group 1

taVNS 30 minutes DEVICE

Sham 45 minutes and taVNS active stimulation for 30 minutes

Dose Group 2

taVNS 45 minutes DEVICE

Sham 30 minutes and taVNS active stimulation for 45 minutes

Dose Group 3

taVNS 60 minutes DEVICE

Sham 15 minutes and taVNS active stimulation for 60 minutes

Dose Group 4

taVNS 75 minutes DEVICE

Sham 0 minutes and taVNS active stimulation for 75 minutes

Dose Group 5

taVNS 0 minutes DEVICE

Sham taVNS 75 minutes

Dose Group 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Danielle Taylor, PhD
• Organization: Wayne State University

dtaylo@med.wayne.edu

6166486793

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: July 6, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)