A Phase 3 interventional study of Methylprednisolone and or prednisolone in Language Disorders in Children, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Ain Shams University · Phase 3, Interventional, and Screening
In general, the severity of the patients' language disorders fluctuated with the degree of EEG epileptiform activity . Since then, a spectrum of disorders, often referred to collectively as the epilepsy-aphasia spectrum, have been described that share features of sleep potentiated EEG abnormalities, cognitive problems, and rare or even absent clinical seizures .
In our study , Investigators evaluated the sleep EEG changes in pediatrics with languague dysfunction then in patients with EEG changes , investigators gave treatment according to type of EEG changes and investigators did a follow up assessment of language , EEG changes and frequency of clinical seizures if present at first .
Language dysfunction is one of the most common problems in paediatrics. There is increased interest in association of epilepsy and epileptiform EEG abnormalities to language dysfunction.
Electrographic status epilepticus in sleep or continuous spike - wave in slow wave during sleep, is a typical feature of acquired epileptic aphasia feature in sleep, or continuous spike-wave in slow-wave sleep, is a typical.
Our study screened for sleep potentiated epileptiform discharges in children with language dysfunction and effect of treatment of these epileptiform discharges on language dysfunction improvement.
The aim of our work :
Patients and methods :
Inclusion Criteria: The study was conducted on Children with :
Exclusion Criteria:
The approval of the Research Ethics Committee at Ain Shams University was obtained ( M.D 4312020 ) .
Study Procedures:
Full history taking:
Clinical examination including:
Clinical diagnostic aids :
Investigations:
Patients whose EEG showed epileptogenic activity ,received treatment and a follow up EEG and Assessment of language age by modified pre-school language screening test - the Arabic version will be done after 6 months.
Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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o Language delay (their language age is below their chronological age ),or Language regression (any convincing report of loss of previously acquired language skills, whether or not prior language development was reported as normal or delayed) (Meilleur et al., 2009)
Exclusion Criteria:
o Patients with hearing problems.
Drug: Methylprednisolone and or prednisolone
we gave methylprednisolone and or prednisolone to patients with EEG activity and follow up the effect of the drug on language
language age of the patient
we follow up language age of the patient after treatment
Time frame: 6 months
Ran from Feb 2020 to primary completion in Nov 2021, 20 months.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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