Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- EEG patterns
研究概览
简要总结
This study is an investigation of the neurologic, immunologic, and rheumatologic markers of Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include anxiety, emotional lability, depression, irritability, aggression, oppositionality, deterioration in school performance, behavioral (developmental) regression, sensory amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is thought to be caused by infection, inflammation, or alternate triggers that is associated with a brain response that leads to these symptoms. The purpose of this study is to examine specific neurologic, immunologic, rheumatologic, and genomic, components in children with the acute-onset of psychiatric symptoms. This research may begin to uncover a much larger story of autoimmune processes that are involved in psychiatric disorders of childhood. By better understanding the etiologic components of psychiatric phenomenon, future treatments may be better targeted to underlying causes.
详细描述
The investigators will recruit 500 children, 1-18 years old at onset with PANS/PANDAS. They will be treatment naive and within one month of onset/exacerbation. The 500 children with PANS will be gender- and age-matched to 100 healthy children, to allow examination of immunologic, neurologic, genomic, and behavioral differences between these two groups of children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with PANS
- •Age 1-18 at onset of PANS
- •Diagnosis of PANS: abrupt onset of OCD or food restriction, and at least two of the following associated symptoms: frequent urination, worsening handwriting/cognition, inattention, anorexia, separation anxiety, oppositionality, irritability/rage outbursts, and emotional lability.
- •Patients must live within 90 miles of Stanford University and have a new onset of PANS illness
- •Patients must have an established pediatrician within 90 miles of Stanford University for 3 years.
- •Healthy Controls
- •No psychiatric diagnosis
排除标准
- •Any neuropsychiatric illness that may obscure the clear diagnosis of PANS
结局指标
主要结局
EEG patterns
时间窗: Through study completion, up to 12 years
The investigators will report results of abnormal EEG patterns from patients with PANS. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Cerebral blood flow
时间窗: Through study completion, up to 12 years
The investigators will report results of altered cerebral blood flow from patients with PANS.
Rapid Eye Movement (REM) motor disinhibition
时间窗: Through study completion, up to 12 years
The investigators will report results of REM motor disinhibition from polysomnography studies. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
次要结局
- Global Impairment Scores(Every 2-4 weeks for up to 12 years)
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)(Every 2-4 weeks for up to 12 years)
- Caregiver Burden Inventory(Every 2-4 weeks for up to 12 years)
- Neurological findings(Every 2-4 weeks for up to 12 years)
- Columbia Impairment Scale(Every 2-4 weeks for up to 12 years)
研究者
Jennifer Frankovich
Clinical Associate Professor
Stanford University