Clinical trial NCT04812015: Learning and Ear Stimulation
Official title: Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning
taVNS
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Heart Rate
timeFrame: Baseline to Active Stimulation (10-80 minutes apart) and Baseline to Recovery (90 minutes apart)
measure: Change in Skin Conductance Levels
timeFrame: Baseline to Active Stimulation (10-80 minutes apart) and Baseline to Recovery (90 minutes apart)
measure: Change in P300 Amplitude
timeFrame: Measured at 20-30, 50-60, and 80-90 minutes during stimulation
measure: Pupillometry (Pupil Response)
timeFrame: Baseline to Active Stimulation (10-80 minutes apart) and Baseline to Recovery (90 minutes apart)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: