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

Primary Purpose

Benign Childhood Epilepsy With Centrotemporal Spikes

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
conventional antiepileptic drugs
oral steroid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Childhood Epilepsy With Centrotemporal Spikes

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History and EEG findings of benign epilepsy with centrotemporal spikes

Exclusion Criteria:

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

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A antiepileptic

B steroid

Arm Description

will receive conventional antiepileptic drugs only

will receive oral steroid for 3 months beside conventional antiepileptic drugs

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2018
Last Updated
August 11, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03490487
Brief Title
Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes
Official Title
Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Anticipated)
Study Completion Date
December 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Childhood Epilepsy With Centrotemporal Spikes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A antiepileptic
Arm Type
Active Comparator
Arm Description
will receive conventional antiepileptic drugs only
Arm Title
B steroid
Arm Type
Experimental
Arm Description
will receive oral steroid for 3 months beside conventional antiepileptic drugs
Intervention Type
Drug
Intervention Name(s)
conventional antiepileptic drugs
Other Intervention Name(s)
carbamazepine, valproate, oxcarbazepine or levetiracetam
Intervention Description
will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
Intervention Type
Drug
Intervention Name(s)
oral steroid
Other Intervention Name(s)
Prednisolone
Intervention Description
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.
Primary Outcome Measure Information:
Title
To detect the effect of oral steroids on normalization of sleep EEG.
Description
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
Title
To detect the effect of oral steroids regarding improvement of cognitive functions of patients with BECTS.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History and EEG findings of benign epilepsy with centrotemporal spikes Exclusion Criteria: Genetic disorders. Metabolic or neurodegenerative disease. Gross motor delay.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal A Abdelal, MD
Phone
+201111686162
Email
Gamal.asker@med.au.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nafisa H Rifaat, MD
Phone
+201003472082
Email
nrefat@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal A Abdelal, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11008297
Citation
Fejerman N, Caraballo R, Tenembaum SN. [Atypical evolutions of benign partial epilepsy of infancy with centro-temporal spikes]. Rev Neurol. 2000 Aug 16-31;31(4):389-96. Spanish.
Results Reference
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PubMed Identifier
19818938
Citation
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Results Reference
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PubMed Identifier
19879197
Citation
Danielsson J, Petermann F. Cognitive deficits in children with benign rolandic epilepsy of childhood or rolandic discharges: a study of children between 4 and 7 years of age with and without seizures compared with healthy controls. Epilepsy Behav. 2009 Dec;16(4):646-51. doi: 10.1016/j.yebeh.2009.08.012. Epub 2009 Oct 29.
Results Reference
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PubMed Identifier
17850323
Citation
Clarke T, Strug LJ, Murphy PL, Bali B, Carvalho J, Foster S, Tremont G, Gagnon BR, Dorta N, Pal DK. High risk of reading disability and speech sound disorder in rolandic epilepsy families: case-control study. Epilepsia. 2007 Dec;48(12):2258-65. doi: 10.1111/j.1528-1167.2007.01276.x. Epub 2007 Sep 10.
Results Reference
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PubMed Identifier
22759211
Citation
Kanemura H, Sano F, Aoyagi K, Sugita K, Aihara M. Do sequential EEG changes predict atypical clinical features in rolandic epilepsy? Dev Med Child Neurol. 2012 Oct;54(10):912-7. doi: 10.1111/j.1469-8749.2012.04358.x. Epub 2012 Jul 4.
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

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