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Идёт набор NCT02889016

Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

— Наблюдательное Pediatric Acute-Onset Neuropsychiatric Syndrome Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections PANS PANDAS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, PANS, PANDAS. Базовые параметры: 4 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Cerebral blood flow [Срок оценки: Through study completion, up to 12 years]
  • EEG patterns [Срок оценки: Through study completion, up to 12 years]
  • Rapid Eye Movement (REM) motor disinhibition [Срок оценки: Through study completion, up to 12 years]
Вторичные конечные точки (5)
  • Global Impairment Scores [Срок оценки: Every 2-4 weeks for up to 12 years]
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Срок оценки: Every 2-4 weeks for up to 12 years]
  • Columbia Impairment Scale [Срок оценки: Every 2-4 weeks for up to 12 years]
  • Caregiver Burden Inventory [Срок оценки: Every 2-4 weeks for up to 12 years]
  • Neurological findings [Срок оценки: Every 2-4 weeks for up to 12 years]

Критерии участия

Критерии включения

  • 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
  • Age 4-18
  • No psychiatric diagnosis

Критерии исключения

  • Any neuropsychiatric illness that may obscure the clear diagnosis of PANS

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Stanford University — Palo Alto

Публикации

  • Swedo SE, Leckman JF, Rose NR (2012) From Research Subgroup to Clinical Syndrome: Modifying the PANDAS Criteria to Describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatr Therapeut 2:113. doi: 10.4172/2161-0665.1000113
  • Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub PMID 25325534
  • Murphy TK, Gerardi DM, Leckman JF. Pediatric acute-onset neuropsychiatric syndrome. Psychiatr Clin North Am. 2014 Sep;37(3):353-74. doi: 10.1016/j.psc.2014.06.001. PMID 25150567

Идентификаторы

NCT: NCT02889016 · 26922

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗