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

NCT03490487 | Unknown Phase 4

• 1 other identifier: DS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Childhood Epilepsy With Centrotemporal Spikes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Study Arms (2)

A antiepileptic

ACTIVE COMPARATOR

will receive conventional antiepileptic drugs only

Drug: conventional antiepileptic drugs

B steroid

EXPERIMENTAL

will receive oral steroid for 3 months beside conventional antiepileptic drugs

Drug: conventional antiepileptic drugs; Drug: oral steroid

Interventions

conventional antiepileptic drugs DRUG

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

A antiepileptic; B steroid

oral steroid DRUG

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

B steroid

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• History and EEG findings of benign epilepsy with centrotemporal spikes

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

RECRUITING

Related Publications (12)

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  PMID: 11008297 BACKGROUND

• Ay Y, Gokben S, Serdaroglu G, Polat M, Tosun A, Tekgul H, Solak U, Kesikci H. Neuropsychologic impairment in children with rolandic epilepsy. Pediatr Neurol. 2009 Nov;41(5):359-63. doi: 10.1016/j.pediatrneurol.2009.05.013.

  PMID: 19818938 BACKGROUND

• 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.

  PMID: 19879197 BACKGROUND

• 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.

  PMID: 17850323 BACKGROUND

• 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.

  PMID: 22759211 BACKGROUND

• Kwon S, Hwang TG, Lee J, Kim DK, Seo HE. Benign childhood epilepsy with centrotemporal spikes: to treat or not to treat. J Epilepsy Res. 2013 Jun 30;3(1):1-6. doi: 10.14581/jer.13001. eCollection 2013 Jun.

  PMID: 24649464 BACKGROUND

• Kwon S, Seo HE, Hwang SK. Cognitive and other neuropsychological profiles in children with newly diagnosed benign rolandic epilepsy. Korean J Pediatr. 2012 Oct;55(10):383-7. doi: 10.3345/kjp.2012.55.10.383. Epub 2012 Oct 29.

  PMID: 23133485 BACKGROUND

• Inutsuka M, Kobayashi K, Oka M, Hattori J, Ohtsuka Y. Treatment of epilepsy with electrical status epilepticus during slow sleep and its related disorders. Brain Dev. 2006 Jun;28(5):281-6. doi: 10.1016/j.braindev.2005.09.004. Epub 2006 Jan 10.

  PMID: 16376508 BACKGROUND

• Kramer U, Sagi L, Goldberg-Stern H, Zelnik N, Nissenkorn A, Ben-Zeev B. Clinical spectrum and medical treatment of children with electrical status epilepticus in sleep (ESES). Epilepsia. 2009 Jun;50(6):1517-24. doi: 10.1111/j.1528-1167.2008.01891.x. Epub 2008 Nov 19.

  PMID: 19054417 BACKGROUND

• Guerrini R, Genton P, Bureau M, Parmeggiani A, Salas-Puig X, Santucci M, Bonanni P, Ambrosetto G, Dravet C. Multilobar polymicrogyria, intractable drop attack seizures, and sleep-related electrical status epilepticus. Neurology. 1998 Aug;51(2):504-12. doi: 10.1212/wnl.51.2.504.

  PMID: 9710026 BACKGROUND

• Scheltens-de Boer M. Guidelines for EEG in encephalopathy related to ESES/CSWS in children. Epilepsia. 2009 Aug;50 Suppl 7:13-7. doi: 10.1111/j.1528-1167.2009.02211.x.

  PMID: 19682043 BACKGROUND

• Chou IC, Chang YT, Chin ZN, Muo CH, Sung FC, Kuo HT, Tsai CH, Kao CH. Correlation between epilepsy and attention deficit hyperactivity disorder: a population-based cohort study. PLoS One. 2013;8(3):e57926. doi: 10.1371/journal.pone.0057926. Epub 2013 Mar 6.

  PMID: 23483944 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Rolandic

Interventions

Carbamazepine; Valproic Acid; Oxcarbazepine; Levetiracetam; Steroids; Prednisolone

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Acetamides; Amides; Acetates; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes

Study Officials

• Gamal A Abdelal, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Gamal A Abdelal, MD

CONTACT

+201111686162; Gamal.asker@med.au.edu.eg

Nafisa H Rifaat, MD

CONTACT

+201003472082; nrefat@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: April 6, 2018
• Study Start: June 20, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 25, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)