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

N/ANot Yet RecruitingNCT07540182

Assiut University25 enrolled

Overview

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

Outcome predictors in children with Acute Disseminated Encephalomyelitis

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Disseminated Encephalomyelitis Encephalomyelitis Encephalopathy

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: 6 months

Secondary Outcomes

Incidence of Disease Relapse

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.

Time frame: up to 12 months

Incidence of Residual Neurological Deficits

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.

Time frame: up to 12 months

Central Contacts

Norma S Girgis

CONTACT

00201274511337 samygergis104@gmail.com

Data from ClinicalTrials.gov

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