Learning and Ear Stimulation

Learning Clinical Trial

Official title:

Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812015
• Other study ID #: Pro00107689
• Status: Completed
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Learning
• taVNS

Intervention

Device:
• transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes
Sham 60 minutes and taVNS active stimulation for 15 minutes
• taVNS 30 minutes
Sham 45 minutes and taVNS active stimulation for 30 minutes
• taVNS 45 minutes
Sham 30 minutes and taVNS active stimulation for 45 minutes
• taVNS 60 minutes
Sham 15 minutes and taVNS active stimulation for 60 minutes
• taVNS 75 minutes
Sham 0 minutes and taVNS active stimulation for 75 minutes
• taVNS 0 minutes
Sham taVNS 75 minutes

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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