NCT03284801

Brief Summary

Acute disseminated encephalomyelitis is an immune-mediated inflammatory demyelinating disease of the central nervous system, which is typically transitory and self-limiting. It is characterized by an acute or subacute encephalopathy with neurological deficits, and magnetic resonance imaging evidence of widespread demyelination that predominantly involves the white matter of the brain and spinal cord. In the absence of specific biological markers, the diagnosis of Acute disseminated encephalomyelitis is still based upon a combination of clinical and neuro imaging features and exclusion of diseases that mimic Acute disseminated encephalomyelitis

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 8, 2017

Last Update Submit

September 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical audit on management of acute disseminating encephalomyelitis

    To improve diagnosis and management of acute disseminated encephalomyelitis in Neurology Unit of Assiut University Children Hospital and to decrease the mortality and residual deficits from this disease. The aim of this audit is to measure the current practice within the Neurology Unit of Assiut University Children Hospital team in the diagnosis and management of acute disseminated encephalomyelitis against the recommendations in American Academy of Neurology guidance by using checklist and designed questionnaire.

    within one year

Interventions

clinical audit on management of acute disseminating encephalomyelitis

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

\- All patient presented with manifestation of acute disseminating encephalomyelitis admitted in Assiut University Children Hospital

You may qualify if:

  • All patient presented with manifestation of acute disseminating encephalomyelitis admitted in Assiut University Children Hospital

You may not qualify if:

  • Patients presented with viral encephalitis,bacterial meningitis
  • Cases not fulfilling MRI criteria for diagnosis of acute disseminated encephalomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Wingerchuk DM. Postinfectious encephalomyelitis. Curr Neurol Neurosci Rep. 2003 May;3(3):256-64. doi: 10.1007/s11910-003-0086-x.

    PMID: 12691631BACKGROUND
  • Tenembaum S, Chitnis T, Ness J, Hahn JS; International Pediatric MS Study Group. Acute disseminated encephalomyelitis. Neurology. 2007 Apr 17;68(16 Suppl 2):S23-36. doi: 10.1212/01.wnl.0000259404.51352.7f.

    PMID: 17438235BACKGROUND
  • Menge T, Kieseier BC, Nessler S, Hemmer B, Hartung HP, Stuve O. Acute disseminated encephalomyelitis: an acute hit against the brain. Curr Opin Neurol. 2007 Jun;20(3):247-54. doi: 10.1097/WCO.0b013e3280f31b45.

    PMID: 17495616BACKGROUND
  • Dale RC, de Sousa C, Chong WK, Cox TC, Harding B, Neville BG. Acute disseminated encephalomyelitis, multiphasic disseminated encephalomyelitis and multiple sclerosis in children. Brain. 2000 Dec;123 Pt 12:2407-22. doi: 10.1093/brain/123.12.2407.

    PMID: 11099444BACKGROUND
  • Hynson JL, Kornberg AJ, Coleman LT, Shield L, Harvey AS, Kean MJ. Clinical and neuroradiologic features of acute disseminated encephalomyelitis in children. Neurology. 2001 May 22;56(10):1308-12. doi: 10.1212/wnl.56.10.1308.

    PMID: 11376179BACKGROUND
  • 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.

    PMID: 12973660BACKGROUND
  • Pohl D, Tenembaum S. Treatment of acute disseminated encephalomyelitis. Curr Treat Options Neurol. 2012 Jun;14(3):264-75. doi: 10.1007/s11940-012-0170-0.

    PMID: 22476745BACKGROUND
  • Cortese I, Chaudhry V, So YT, Cantor F, Cornblath DR, Rae-Grant A. Evidence-based guideline update: Plasmapheresis in neurologic disorders [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2011 Jan 18;76(3):294-300. doi: 10.1212/WNL.0b013e318207b1f6.

    PMID: 21242498BACKGROUND
  • Keegan M, Pineda AA, McClelland RL, Darby CH, Rodriguez M, Weinshenker BG. Plasma exchange for severe attacks of CNS demyelination: predictors of response. Neurology. 2002 Jan 8;58(1):143-6. doi: 10.1212/wnl.58.1.143.

    PMID: 11781423BACKGROUND

MeSH Terms

Conditions

Encephalomyelitis, Acute Disseminated

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesLeukoencephalopathiesBrain DiseasesCentral Nervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marwa Alsaid Ahmed, resident doctor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Farouk Alsayed hassanen, prof

CONTACT

Eman Fath Allah, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 15, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

September 15, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share