ADAM'S Prognostic Markers

NCT ID: NCT07188194

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-10-31

Brief Summary

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Acute Disseminated Encephalomyelitis (ADEM) is an immune-mediated demyelinating disorder of the central nervous system that predominantly affects children. It typically presents with an acute onset of multifocal neurological symptoms, often preceded by a viral infection or, less commonly, vaccination. ADEM is characterized radiologically by widespread, bilateral, asymmetric lesions in the brain and spinal cord, and is often monophasic in nature.

Despite generally favorable outcomes, a subset of patients may experience significant neurological sequelae, prolonged recovery, or even conversion to chronic demyelinating disorders such as multiple sclerosis (MS) or multiphasic ADEM. The early identification of patients at risk for poor outcomes remains a clinical challenge, as the course of the disease is highly variable.

Cerebrospinal fluid (CSF) analysis and magnetic resonance imaging (MRI) are essential components in the diagnostic workup of ADEM. Certain CSF features-such as pleocytosis, elevated protein levels, or the presence of oligoclonal bands-may reflect the underlying immunological activity and CNS inflammation. Similarly, specific MRI characteristics-such as lesion distribution, size, contrast enhancement, or involvement of deep gray matter-may correlate with disease severity and long-term prognosis.

The clinical presentation of ADEM is heterogeneous. Common features include encephalopathy (ranging from irritability to coma), seizures, motor deficits, ataxia, visual disturbances, and brainstem symptoms. The severity and combination of these manifestations can vary widely between patients. Several studies suggest that certain clinical features may correlate with poorer prognosis, such as prolonged or deep coma, recurrent seizures, early need for intensive care, and delayed initiation of immunotherapy.

Detailed Description

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* To evaluate the prognostic value of cerebrospinal fluid (CSF) and magnetic resonanceimaging (MRI) findings at initial presentation in predicting six months neurological outcomes in pediatric patients diagnosed with ADEM.
* Secondary aim : correlation between clinical presentation and prognosis.

Conditions

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Acute Disseminated Encephalomyelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. \- First episode of acute disseminated encephalomyelitis( ADEM).
2. \- MRI and cerebrospinal fluid (CSF) performed within 7 days of symptom onset.
3. \- Age from 6 months up to 18 years

Exclusion Criteria

1. \- History of prior demyelinating events
2. \- Alternative diagnoses (e.g., CNS infections, metabolic disorders).
Minimum Eligible Age

6 Minutes

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Alaa AboAlkasem Mohamed

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Alaa A Alkasem, Master

Role: CONTACT

01062805486

References

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Anlar B, Basaran C, Kose G, Guven A, Haspolat S, Yakut A, Serdaroglu A, Senbil N, Tan H, Karaagaoglu E, Karli Oguz K. Acute disseminated encephalomyelitis in children: outcome and prognosis. Neuropediatrics. 2003 Aug;34(4):194-9. doi: 10.1055/s-2003-42208.

Reference Type BACKGROUND
PMID: 12973660 (View on PubMed)

Krupp LB, Tardieu M, Amato MP, Banwell B, Chitnis T, Dale RC, Ghezzi A, Hintzen R, Kornberg A, Pohl D, Rostasy K, Tenembaum S, Wassmer E; International Pediatric Multiple Sclerosis Study Group. International Pediatric Multiple Sclerosis Study Group criteria for pediatric multiple sclerosis and immune-mediated central nervous system demyelinating disorders: revisions to the 2007 definitions. Mult Scler. 2013 Sep;19(10):1261-7. doi: 10.1177/1352458513484547. Epub 2013 Apr 9.

Reference Type BACKGROUND
PMID: 23572237 (View on PubMed)

Verhey LH, Branson HM, Shroff MM, Callen DJ, Sled JG, Narayanan S, Sadovnick AD, Bar-Or A, Arnold DL, Marrie RA, Banwell B; Canadian Pediatric Demyelinating Disease Network. MRI parameters for prediction of multiple sclerosis diagnosis in children with acute CNS demyelination: a prospective national cohort study. Lancet Neurol. 2011 Dec;10(12):1065-73. doi: 10.1016/S1474-4422(11)70250-2. Epub 2011 Nov 6.

Reference Type BACKGROUND
PMID: 22067635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27572859 (View on PubMed)

Other Identifiers

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ADAM'S prognostic markers

Identifier Type: -

Identifier Source: org_study_id

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