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

Benign Childhood Epilepsy With Centrotemporal Spikes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03490487
• Other study ID #: DS
• Status: Recruiting
• Phase: Phase 4
• Start date: June 20, 2018
• Est. completion date: December 25, 2020

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Gamal A Abdelal, MD
• Phone: +201111686162
• Email: Gamal.asker[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 25, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

Inclusion Criteria:

• History and EEG findings of benign epilepsy with centrotemporal spikes

Exclusion Criteria:

• Genetic disorders.

• Metabolic or neurodegenerative disease.

• Gross motor delay.

Related Conditions & MeSH terms

• Benign Childhood Epilepsy With Centrotemporal Spikes
• Epilepsy
• Epilepsy, Rolandic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

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. — View Citation

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. — View 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. Epub 2007 Sep 10. — View 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. — View 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. — View Citation

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. — View Citation

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. Epub 2006 Jan 10. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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