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

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Benign Childhood Epilepsy With Centrotemporal Spikes

Treatments: Drug: conventional antiepileptic drugs; Drug: oral steroid

Study type: Interventional

Funder types: Other

Identifiers

NCT03490487

DS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A antiepileptic

Active Comparator group

Description:

will receive conventional antiepileptic drugs only

Treatment:

Drug: conventional antiepileptic drugs

B steroid

Experimental group

Description:

will receive oral steroid for 3 months beside conventional antiepileptic drugs

Treatment:

Drug: oral steroid

Drug: conventional antiepileptic drugs