Management Strategies For Electrical Status Epilepticus During Sleep

• Sponsor: Randa Abdelbadie Abdelaleem (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03251820
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 32

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: corticosteroid

Detailed Description

Electrical status epilepticus in sleep (ESES), also known as continuous spikes and waves during slow sleep (CSWS), is an age related, self - limiting disorder characterized by:

1. epilepsy with different seizure types,

2. neuropsychological regression, and

3. typical EEG pattern of continuous epileptiform activity during non-rapid eye movement sleep (NREM).

During wakefulness, the EEG shows focal/multifocal spikes that increase in frequency during the acute stage. During sleep, ESES appears and is characterized by (1) marked potentiation of epileptiform discharges during non-REM sleep, leading to (2) a (near)-continuous, bilateral, or occasionally lateralized slow spikes and waves, (3) and these spikes and waves occur "during a significant proportion" of the non-REM sleep with a threshold ranging from 25% to 85%

The exact incidence of CSWS is not known. In pediatric neurology clinics, a reported frequency of 0.2% of childhood epilepsies most probably underestimates the incidence of CSWS.

CSWS is a devastating syndrome, which requires prompt treatment, the efficacy of which is checked with regular intervals, e.g. three or six months. Although epilepsy resolves with time in most cases, many children are left with significant cognitive or language impairment. Longer duration of ESES appears to be the major predictor of poor outcome.

So, early recognition and effective therapy are necessary to improve long-term prognosis in this condition.

The goal of treatment is not only to control clinical seizures but also to improve neuropsychological functions and prevent potential cognitive deterioration. There was no agreement on best treatment, but potential candidates included high-dose benzodiazepines, valproate, levetiracetam, and corticosteroids.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Management Strategies for Electrical Status Epilepticus During Sleep
• Anticipated Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Oct 1, 2019
• Anticipated Study Completion Date: Oct 1, 2020

Outcome Measures

Primary Outcome Measures

1. Cognitive ability [IQ measured before treatment and after completing treatment course and then every three months for one year]

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

2. Interictal epileptiform activity [EEG will be done every three months for upto one year after discontinuation of therapy]

   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.

Secondary Outcome Measures

1. Change in seizure frequency [Measured before and one year after treatment]

   Compare the frequency of seizures before the start of treatment and after the start of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Randa Abdelbadie Abdelaleem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Randa Abdelbadie Abdelaleem, Assistant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT03251820
• Other Study ID Numbers: MSESES
• First Posted: Aug 16, 2017
• Last Update Posted: Jan 12, 2018
• Last Verified: Aug 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Randa Abdelbadie Abdelaleem, Assistant lecturer, Assiut University: electrical status epilepticus during slow wave sleep; seizure; cognition; continuous spikes and waves during sleep
• Additional relevant MeSH terms: Status Epilepticus

Study Results

No Results Posted as of Jan 12, 2018