Management Strategies For Electrical Status Epilepticus During Sleep

NCT03251820 | Unknown DMC

• 1 other identifier: MSESES
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Electrical status epilepticus during slow wave sleep is a condition in which the epileptic patient starts to develop neurocognitive deterioration, any type of seizures and continuous electrical activity in the EEG during non rapid eye movement sleep. It is an age related condition and will resolve spontaneously at around the age of puberty. However if left untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration. Thus early diagnosis and treatment is essential in these children to preserve neurocognitive function.

Conditions

Epilepsy

Keywords

electrical status epilepticus during slow wave sleep; seizure; cognition; continuous spikes and waves during sleep

Outcome Measures

Primary Outcomes (2)

• Cognitive ability

  Change in cognitive ability in response to steroids and benzodiazepines by IQ assessment using using Standford - Binnet scales version V.

  IQ measured before treatment and after completing treatment course and then every three months for one year

• Interictal epileptiform activity

  epileptiform activity will be assessed by EEG recordings during sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration.

  EEG will be done every three months for upto one year after discontinuation of therapy

Secondary Outcomes (1)

• Change in seizure frequency

  Measured before and one year after treatment

Interventions

corticosteroid DRUG

Each patient will be subjected to a one month course of steroids and then re-evaluated

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Those patients who fulfill the inclusion criteria attending the neurology unit at Assiut University Children Hospital will be administered the following treatment: 1. Nocturnal diazepam for three months 2. Corticosteroids tapered over one months 3. Antiepileptic drug other than sodium channel blockers which will be continued for at least two years. During the course of the treatment the patients will be followed up by sleep EEG and IQ before and at least one month after the start of treatment and regularly every three months for at least one year after discontinuation of benzodiazepines and steroids.

You may qualify if:

• All epileptic patients above 2 years of age presenting with neuropsychological deterioration, seizures and ESES in NREM sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration. SWI must be at least 25% or more.

You may not qualify if:

• Any epileptic patient not presenting with typical EEG findings and neurocognitive regression.

Sponsors & Collaborators

• Randa Abdelbadie Abdelaleem: lead

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

El - Sayed Kh Abdel - Karim

CONTACT

01060805170; khalilsay@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: February 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: January 12, 2018

Record last verified: 2017-08