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临床试验/NCT07188194
NCT07188194尚未招募不适用

Prospective Value of Clinical , CSF and MRI Findings in Pediatric Acute Disseminated Encephalomyelitis

Assiut University0 个研究点目标入组 32 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
主要终点
Neurological status assessed by the National Institutes of Health Stroke Scale (NIHSS)

研究概览

简要总结

Acute Disseminated Encephalomyelitis (ADEM) is an immune-mediated demyelinating disorder of the central nervous system that predominantly affects children. It typically presents with an acute onset of multifocal neurological symptoms, often preceded by a viral infection or, less commonly, vaccination. ADEM is characterized radiologically by widespread, bilateral, asymmetric lesions in the brain and spinal cord, and is often monophasic in nature.

Despite generally favorable outcomes, a subset of patients may experience significant neurological sequelae, prolonged recovery, or even conversion to chronic demyelinating disorders such as multiple sclerosis (MS) or multiphasic ADEM. The early identification of patients at risk for poor outcomes remains a clinical challenge, as the course of the disease is highly variable.

Cerebrospinal fluid (CSF) analysis and magnetic resonance imaging (MRI) are essential components in the diagnostic workup of ADEM. Certain CSF features-such as pleocytosis, elevated protein levels, or the presence of oligoclonal bands-may reflect the underlying immunological activity and CNS inflammation. Similarly, specific MRI characteristics-such as lesion distribution, size, contrast enhancement, or involvement of deep gray matter-may correlate with disease severity and long-term prognosis.

The clinical presentation of ADEM is heterogeneous. Common features include encephalopathy (ranging from irritability to coma), seizures, motor deficits, ataxia, visual disturbances, and brainstem symptoms. The severity and combination of these manifestations can vary widely between patients. Several studies suggest that certain clinical features may correlate with poorer prognosis, such as prolonged or deep coma, recurrent seizures, early need for intensive care, and delayed initiation of immunotherapy.

详细描述

  • To evaluate the prognostic value of cerebrospinal fluid (CSF) and magnetic resonanceimaging (MRI) findings at initial presentation in predicting six months neurological outcomes in pediatric patients diagnosed with ADEM.
  • Secondary aim : correlation between clinical presentation and prognosis.

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
6 Minutes 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - First episode of acute disseminated encephalomyelitis( ADEM).
  • - MRI and cerebrospinal fluid (CSF) performed within 7 days of symptom onset.
  • - Age from 6 months up to 18 years

排除标准

  • - History of prior demyelinating events
  • - Alternative diagnoses (e.g., CNS infections, metabolic disorders).

结局指标

主要结局

Neurological status assessed by the National Institutes of Health Stroke Scale (NIHSS)

时间窗: At 3 months, and 6 months

The NIHSS quantifies neurological impairment. Scores range from 0 (no deficit) to 42 (severe stroke). Higher scores indicate worse neurological status.

次要结局

  • Functional outcome assessed by the Modified Rankin Scale (mRS)(At 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa AboAlkasem Mohamed

Resident

Assiut University

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