Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

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ClinicalTrials.gov Identifier: NCT03490487

Recruitment Status : Recruiting

First Posted : April 6, 2018

Last Update Posted : August 13, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Khalaf A Sayed, Assiut University

Tracking Information

First Submitted Date ^ICMJE

February 18, 2018

First Posted Date ^ICMJE

April 6, 2018

Last Update Posted Date

August 13, 2020

Actual Study Start Date ^ICMJE

June 20, 2018

Estimated Primary Completion Date

December 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To detect the effect of oral steroids on normalization of sleep EEG. [ Time Frame: 3 months ]
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.
To detect the effect of oral steroids regarding improvement of cognitive functions of patients with BECTS. [ Time Frame: 3 months ]
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.

Original Primary Outcome Measures ^ICMJE

To compare between the effect of oral steroids and diazepam regarding normalization of sleep EEG. [ Time Frame: 3 months ]
follow up Electroencephalography and calculation of spike-wave index before and after three months of treatment with diazepam and steroid.Any reduction in spike wave index on electroencephalograph after receiving diazepam or 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.
To compare between the effect of oral steroids and diazepam regarding improvement of cognitive functions of patients with BECTS. [ Time Frame: 3 months ]
Intelligence quotient assessment with Stanford-Binet scales will be done before and after three months of treatment with diazepam and 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.

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

Official Title ^ICMJE

Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Benign Childhood Epilepsy With Centrotemporal Spikes

Intervention ^ICMJE

Drug: conventional antiepileptic drugs
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.

Other Name: carbamazepine, valproate, oxcarbazepine or levetiracetam
Drug: oral steroid
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.

Other Name: Prednisolone

Study Arms ^ICMJE

Active Comparator: A antiepileptic
will receive conventional antiepileptic drugs only

Intervention: Drug: conventional antiepileptic drugs
Experimental: B steroid
will receive oral steroid for 3 months beside conventional antiepileptic drugs
Interventions:
- Drug: conventional antiepileptic drugs
- Drug: oral steroid

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 25, 2020

Estimated Primary Completion Date

December 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

History and EEG findings of benign epilepsy with centrotemporal spikes

Exclusion Criteria:

Genetic disorders.
Metabolic or neurodegenerative disease.
Gross motor delay.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

3 Years to 14 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Gamal A Abdelal, MD	+201111686162	Gamal.asker@med.au.edu.eg
Contact: Nafisa H Rifaat, MD	+201003472082	nrefat@aun.edu.eg

Listed Location Countries ^ICMJE

Egypt

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03490487

Other Study ID Numbers ^ICMJE

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Responsible Party

Khalaf A Sayed, Assiut University

Study Sponsor ^ICMJE

Assiut University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Gamal A Abdelal, MD

Assiut University

PRS Account

Assiut University

Verification Date

August 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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