Learning and Ear Stimulation

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Learning; taVNS

Treatments: Device: taVNS 60 minutes; Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes; Device: taVNS 0 minutes; Device: taVNS 45 minutes; Device: taVNS 75 minutes; Device: taVNS 30 minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT04812015

Pro00107689

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 6 patient groups

Dose Group 1

Other group

Treatment:

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

Dose Group 2

Other group

Treatment:

Device: taVNS 30 minutes

Dose Group 3

Other group

Treatment:

Device: taVNS 45 minutes

Dose Group 4

Other group

Treatment:

Device: taVNS 60 minutes

Dose Group 5

Other group

Treatment:

Device: taVNS 75 minutes

Dose Group 6

Other group

Treatment:

Device: taVNS 0 minutes