NCT05618054招募中不适用
Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Periaqueductal gray region activation - looming task
研究概览
简要总结
This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 12-21 years old
- •Able to communicate and provide consent/assent
- •English speaking
- •Diagnosed with POTS (POTS will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically)
- •Age-matched healthy control subjects: no POTS or other neurological disorders
排除标准
- •Inflammatory arthritis, connective tissue or auto-immune disorder
- •Any chronic neurological disorder besides POTS
- •Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
- •Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
- •Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
- •Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
- •Current substance or alcohol abuse
- •Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
- •Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
- •Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
- •Chronic use of narcotics for pain
- •Claustrophobia or any metal hardware that may interfere with MRI
- •Investigators and study staff
研究组 & 干预措施
Adolescents with POTS
Other
干预措施: Looming task (Behavioral)
Adolescents without POTS
Other
干预措施: Looming task (Behavioral)
结局指标
主要结局
Periaqueductal gray region activation - looming task
时间窗: 90 minutes
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task
Periaqueductal gray region activation - resting
时间窗: 90 minutes
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest
次要结局
未报告次要终点
研究者
研究点 (1)
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