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

April 17, 2026 updated by: Norma Samy Gergis, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Outcome predictors in children with Acute Disseminated Encephalomyelitis

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 29, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADEM disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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