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

NCT07540182 | Not Yet Recruiting

• 1 other identifier: ADEM disease
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Disseminated Encephalomyelitis; Encephalomyelitis; Encephalopathy

Keywords

ADEM; Pediatric Encephalomyelitis; Demyelinating Disorders

Outcome Measures

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.

  6 months

Secondary Outcomes (2)

• Incidence of Disease Relapse

  up to 12 months

• Incidence of Residual Neurological Deficits

  up to 12 months

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Wang CX. Assessment and Management of Acute Disseminated Encephalomyelitis (ADEM) in the Pediatric Patient. Paediatr Drugs. 2021 May;23(3):213-221. doi: 10.1007/s40272-021-00441-7. Epub 2021 Apr 8.

  PMID: 33830467 BACKGROUND

• Sechi E, Krecke KN, Messina SA, Buciuc M, Pittock SJ, Chen JJ, Weinshenker BG, Lopez-Chiriboga AS, Lucchinetti CF, Zalewski NL, Tillema JM, Kunchok A, Monaco S, Morris PP, Fryer JP, Nguyen A, Greenwood T, Syc-Mazurek SB, Keegan BM, Flanagan EP. Comparison of MRI Lesion Evolution in Different Central Nervous System Demyelinating Disorders. Neurology. 2021 Sep 14;97(11):e1097-e1109. doi: 10.1212/WNL.0000000000012467. Epub 2021 Jul 14.

  PMID: 34261784 BACKGROUND

• Pohl D, Alper G, Van Haren K, Kornberg AJ, Lucchinetti CF, Tenembaum S, Belman AL. Acute disseminated encephalomyelitis: Updates on an inflammatory CNS syndrome. Neurology. 2016 Aug 30;87(9 Suppl 2):S38-45. doi: 10.1212/WNL.0000000000002825.

  PMID: 27572859 BACKGROUND

• Ferenc K, Semik P, Paprocka J. Acute Disseminated Encephalomyelitis (ADEM): Current View into Etiopathogenesis and Clinical Features. Brain Sci. 2026 Feb 9;16(2):201. doi: 10.3390/brainsci16020201.

  PMID: 41750202 BACKGROUND

MeSH Terms

Conditions

Encephalomyelitis, Acute Disseminated; Encephalomyelitis; Brain Diseases; Demyelinating Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Norma S Girgis

CONTACT

00201274511337; samygergis104@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Assiut University Hospitals

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 20, 2026
• Study Start: March 29, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04