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Not yet recruitingNCT07540182ADEM diseaseUpdated Apr 20, 2026

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

An observational study in Acute Disseminated Encephalomyelitis, Encephalomyelitis and Encephalopathy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
6 Months to 18 Years
Sex
All
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Study summary

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

Read the detailed description

Outcome predictors in children with Acute Disseminated Encephalomyelitis

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Conditions studied

  • Acute Disseminated Encephalomyelitis
  • Encephalomyelitis
  • Encephalopathy

Keywords

  • ADEM
  • Pediatric Encephalomyelitis
  • Demyelinating Disorders
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In context

Encephalomyelitis

6 studies on the registry are indexed under Encephalomyelitis; 2 are open to participants now.

Browse Encephalomyelitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Target follow-up
25 Months
Patient registry
Yes
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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33830467 ↗
  • 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. PubMed 34261784 ↗
  • 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. PubMed 27572859 ↗
  • 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. PubMed 41750202 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07540182
Lead sponsor
Assiut University
Responsible party
Norma Samy Gergis (Resident at Assiut University Hospitals, Assiut University) — Principal investigator
First posted
Apr 20, 2026
Start date
Mar 29, 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Norma S Girgis
Contact
samygergis104@gmail.com
00201274511337

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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