Acute Disseminated EncephalomyelitisNCT07188194
ADAM'S Prognostic Markers
An observational study of Acute Disseminated Encephalomyelitis, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 minutes to 18 years
- Conditions the study is for
- Acute Disseminated Encephalomyelitis
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 minutes to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 6 months -1 Year diagnosed with ADEM
Who may be able to join
- - First episode of acute disseminated encephalomyelitis( ADEM).
- - MRI and cerebrospinal fluid (CSF) performed within 7 days of symptom onset.
- - Age from 6 months up to 18 years
Who cannot join
- - History of prior demyelinating events
- - Alternative diagnoses (e.g., CNS infections, metabolic disorders).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Value of Clinical , CSF and MRI Findings in Pediatric Acute Disseminated Encephalomyelitis
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.
Read more
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.
Read the detailed description
- 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
- Acute Disseminated Encephalomyelitis
- Medical subject headings
- Encephalomyelitis, Acute Disseminated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological status assessed by the National Institutes of Health Stroke Scale (NIHSS)
The NIHSS quantifies neurological impairment. Scores range from 0 (no deficit) to 42 (severe stroke). Higher scores indicate worse neurological status.
Measured: At 3 months, and 6 months
Secondary outcomes (1)
Functional outcome assessed by the Modified Rankin Scale (mRS)
The mRS measures the degree of disability or dependence in daily activities. Scores range from 0 (no symptoms) to 6 (death). Higher scores indicate worse functional outcomes.
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Disseminated EncephalomyelitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa AboAlkasem Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188194
- Sponsor's protocol ID
- ADAM'S prognostic markers
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12973660Krupp 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.
PubMed 23572237Verhey 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.
PubMed 22067635Pohl 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Value of Clinical , CSF and MRI Findings in Pediatric Acute Disseminated Encephalomyelitis
- ClinicalTrials.gov ID
- NCT07188194
- Acronym / sponsor ID
- ADAM'S prognostic markers
- Conditions
- Acute Disseminated Encephalomyelitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | – |
Who may qualify
- Ages
- 6 minutes to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 6 months -1 Year diagnosed with ADEM
Key inclusion criteria (3 listed)
- - First episode of acute disseminated encephalomyelitis( ADEM).
- - MRI and cerebrospinal fluid (CSF) performed within 7 days of symptom onset.
- - Age from 6 months up to 18 years
Key exclusion criteria (2 listed)
- - History of prior demyelinating events
- - Alternative diagnoses (e.g., CNS infections, metabolic disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological status assessed by the National Institutes of Health Stroke Scale (NIHSS)
Time frame: At 3 months, and 6 months
The NIHSS quantifies neurological impairment. Scores range from 0 (no deficit) to 42 (severe stroke). Higher scores indicate worse neurological status.
1 secondary outcome
Functional outcome assessed by the Modified Rankin Scale (mRS)
Time frame: At 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Results publication: PubMed 12973660Anlar 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.
- Results publication: PubMed 23572237Krupp 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.
- Results publication: PubMed 22067635Verhey 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.
- Results publication: PubMed 27572859Pohl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Disseminated Encephalomyelitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa A Alkasem, Master (01062805486, alaaaboalkasem123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological status assessed by the National Institutes of Health Stroke Scale (NIHSS) (time frame: At 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07188194, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.