Learning and Ear Stimulation

Not Applicable

Completed

• Conditions: taVNS; Learning
• Interventions: Device: taVNS 45 minutes; Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes; Device: taVNS 60 minutes; Device: taVNS 75 minutes; Device: taVNS 30 minutes; Device: taVNS 0 minutes

• Registration Number: NCT04812015
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Study Start: 2022-07-06
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Group 3	taVNS 45 minutes	-
Dose Group 1	transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes	-
Dose Group 4	taVNS 60 minutes	-
Dose Group 5	taVNS 75 minutes	-
Dose Group 2	taVNS 30 minutes	-
Dose Group 6	taVNS 0 minutes	-

Primary Outcome Measures

Name	Time	Method
Change in P300 Amplitude	Measured at 20-30, 50-60, and 80-90 minutes during stimulation	Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 3 intervals during stimulation.
Change in Heart Rate	Baseline to Active Stimulation (10-80 minutes apart) and Baseline to Recovery (90 minutes apart)
Change in Skin Conductance Levels	Baseline to Active Stimulation (10-80 minutes apart) and Baseline to Recovery (90 minutes apart)	Galvanic Skin Response measured in micro Siemens (mS)
Pupillometry (Pupil Response)	Baseline to Active Stimulation (10-80 minutes apart) and Baseline to Recovery (90 minutes apart)	Tonic Pupil Size and Event-Related Pupil Dilation measured in millimeters (mm)

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States