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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Children aged from 6 months old to 18 years. 2. Presence of clinical signs of acute encephalopathy with multifocal neurological deficits

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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