A Phase 4 interventional study of conventional antiepileptic drugs and oral steroid in Benign Childhood Epilepsy With Centrotemporal Spikes, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
Benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in children. It is known to be age-dependent and presumably genetic. Age of onset ranges from one to fourteen years and it represents fifteen percent to twenty five percent of epilepsy in children under 15 years of age.
Generally, Benign epilepsy with centro-temporal spikes is characterized by infrequent focal sensorimotor seizures in the face during sleep, which may secondarily generalize, along with spike-wave discharges, reflecting nonlesional cortical excitability from rolandic regions.
The prognosis is usually considered to be excellent. Over the past years, however, some investigators have questioned whether Benign epilepsy with centro-temporal spikes is indeed benign, considering the variety of different presentations associated with the disorder.It is not uncommon for Benign epilepsy with centro-temporal spikes to be associated with neuropsychological deficits, such as linguistic, cognitive, and behavioral impairment. In particular, reading difficulties and speech/language disorders are more common in children with Benign epilepsy with centro-temporal spikes than in healthy controls.Various neuropsychological deficits seem to be very dependent on the spike index, as well as the predominant localization of epileptiform discharges.Furthermore, the frequency of epileptiform discharges is closely related not only to the degree of neuropsychological deficits, but also to an atypical evolution of benign epilepsy with centro-temporal spikes.
The high comorbid prevalence of attention deficit hyperactivity disorder and epilepsy suggests that there is a bidirectional relationship between these disorders .Cognitive impairment and attention problems are particularly crucial issues in children with epilepsy who are in a vigorous phase of neurodevelopment.
Resolution of continuous spike-and-wave during sleep had been achieved with conventional antiepileptic drugs including ethosuximide, valproic acid, levetiracetam, and sulthiame. When these agents fail to normalize the EEG, a trial with second-line agents such as steroids or high-dose diazepam is attempted.
23 studies on the registry are indexed under Epilepsy, Rolandic; 3 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 13 interventional studies indexed under Epilepsy, Rolandic.
Browse Epilepsy, Rolandic studies →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.
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Exclusion Criteria:
will receive conventional antiepileptic drugs only
Drug: conventional antiepileptic drugs
will receive oral steroid for 3 months beside conventional antiepileptic drugs
Drug: conventional antiepileptic drugs · Drug: oral steroid
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Also known as: carbamazepine, valproate, oxcarbazepine or levetiracetam
will receive oral steroid for 3 months beside conventional antiepileptic drugs. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Also known as: Prednisolone
To detect the effect of oral steroids on normalization of sleep EEG.
follow up Electroencephalography and calculation of spike-wave index before and after three months of treatment with steroid.Any reduction in spike wave index on electroencephalograph after receiving steroid will be considered improvement.The EEG technicians will be requested to perform a prolonged daytime nap EEG. The researcher first will look at the full sleep recording and visually pick the epoch with the highest spike density. The counting start with a page of a high spike density and continued for 10 consecutive minutes. Each page will be scored separately. Each second which contained spikes, either focal or generalized, will be considered positive, and the total number of positive seconds per page will be calculated as percents of the whole page. At the end of the counting, an average of 60 pages (10 min) will be performed and then displayed in terms of the nearest ten percentile number.
Time frame: 3 months
To detect the effect of oral steroids regarding improvement of cognitive functions of patients with BECTS.
Intelligence quotient assessment with Stanford-Binet scales will be done before and after three months of treatment with steroid. Stanford-Binet Intelligence Scale (Fourth Edition) score: very superior (140 and above), superior (120-139), high average (110-119), normal average (90-109), low average (80-89), borderline defective (70-79), mentally defective (30-69). Higher scores will be considered a better or outcome.
Time frame: 3 months
Plan to share: No
Started Jun 2018 (actual). Primary completion is estimated for Dec 2020, 29 months after the start.
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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Steroids