Skip to content

ADAM'S Prognostic Markers

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07188194
Enrollment
32
Registered
2025-09-23
Start date
2025-09-30
Completion date
2026-10-31
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Disseminated Encephalomyelitis

Brief summary

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.

Detailed description

* 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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Minutes to 18 Years
Healthy volunteers
No

Inclusion criteria

1. \- First episode of acute disseminated encephalomyelitis( ADEM). 2. \- MRI and cerebrospinal fluid (CSF) performed within 7 days of symptom onset. 3. \- Age from 6 months up to 18 years

Exclusion criteria

1. \- History of prior demyelinating events 2. \- Alternative diagnoses (e.g., CNS infections, metabolic disorders).

Design outcomes

Primary

MeasureTime frameDescription
Neurological status assessed by the National Institutes of Health Stroke Scale (NIHSS)At 3 months, and 6 monthsThe NIHSS quantifies neurological impairment. Scores range from 0 (no deficit) to 42 (severe stroke). Higher scores indicate worse neurological status.

Secondary

MeasureTime frameDescription
Functional outcome assessed by the Modified Rankin Scale (mRS)At 3 months and 6 monthsThe mRS measures the degree of disability or dependence in daily activities. Scores range from 0 (no symptoms) to 6 (death). Higher scores indicate worse functional outcomes.

Contacts

Primary ContactAlaa A Alkasem, Master
alaaaboalkasem123@gmail.com01062805486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026