Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2022-07-06
2023-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Dose Group 1
transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes
Sham 60 minutes and taVNS active stimulation for 15 minutes
Dose Group 2
taVNS 30 minutes
Sham 45 minutes and taVNS active stimulation for 30 minutes
Dose Group 3
taVNS 45 minutes
Sham 30 minutes and taVNS active stimulation for 45 minutes
Dose Group 4
taVNS 60 minutes
Sham 15 minutes and taVNS active stimulation for 60 minutes
Dose Group 5
taVNS 75 minutes
Sham 0 minutes and taVNS active stimulation for 75 minutes
Dose Group 6
taVNS 0 minutes
Sham taVNS 75 minutes
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00107689
Identifier Type: -
Identifier Source: org_study_id
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