The Aim of the Present Study is to Determine Outcome Predictors in Children Who Were Diagnosed as Acute Disseminated Encephalomyelitis (ADEM).

The aim of the present study is to determine outcome predictors in children who were diagnosed as acute disseminated encephalomyelitis (ADEM).

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Key information

Conditions

Acute Disseminated Encephalomyelitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Central Nervous System Infections Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Encephalomyelitis Encephalomyelitis, Acute Disseminated Encephalopathy Immune System Diseases Infections Leukoencephalopathies Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Outcome predictors in children with Acute Disseminated Encephalomyelitis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged from 6 months old to 18 years.
Presence of clinical signs of acute encephalopathy with multifocal neurological deficits.
MRI findings suggestive of demyelinating lesions.

Exclusion criteria

Pediatric patients diagnosed who were as multiple sclerosis.
Pediatric patients with clinical signs and radiological findings suggestive of neuromyelitis optica spectrum disorder.
Pediatric patients with infectious encephalitis.
Pediatric patients with metabolic or genetic neurological disorders

Treatment and study plan

Primary outcomes

Proportion of Patients Achieving Complete Recovery Assessed by the Modified Rankin Scale (mRS)

Time frame: 6 months

Functional disability and recovery are assessed using the Modified Rankin Scale (mRS), a validated 7-point scale ranging from 0 to 6. A score of 0 indicates no symptoms at all, 5 indicates severe disability (bedridden, requiring constant care), and 6 indicates death. For this study, complete recovery is defined as achieving an mRS score of 0 or 1 (no significant disability). This measure reports the percentage of participants who meet this specific recovery criteria.

Secondary outcomes

Incidence of Disease Relapse

Time frame: up to 12 months

This measure evaluates the percentage of participants who experience a new inflammatory demyelinating event. As per the study protocol, a relapse is specifically defined as the onset of a new neurological event occurring more than 3 months after the patient's initial clinical recovery.
Incidence of Residual Neurological Deficits

Time frame: up to 12 months

This measure reports the proportion of participants who exhibit long-term cognitive or motor sequelae following the acute disease phase. The presence or absence of these residual deficits is determined through standard clinical neurological examinations conducted during outpatient follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Norma S Girgis

CONTACT

[email protected]

00201274511337

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Outcome Predictors in Children With Acute Disseminated Encephalomyelitis at Assuit University Children Hospital

Acronym: ADEM disease

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 20, 2026
Registry last updated: Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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