Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in P300 Amplitude
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Dose Group 6
干预措施: taVNS 0 minutes (Device)
Dose Group 1
干预措施: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes (Device)
Dose Group 2
干预措施: taVNS 30 minutes (Device)
Dose Group 3
干预措施: taVNS 45 minutes (Device)
Dose Group 4
干预措施: taVNS 60 minutes (Device)
Dose Group 5
干预措施: taVNS 75 minutes (Device)
结局指标
主要结局
Change in P300 Amplitude
时间窗: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes
Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.
Change in Heart Rate Variability
时间窗: Baseline to end of Active Stimulation
次要结局
未报告次要终点