EpilepsyNCT03251820
Management Strategies For Electrical Status Epilepticus During Sleep
An observational study of Epilepsy, run by Randa Abdelbadie Abdelaleem.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- corticosteroid
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Any epileptic patient not presenting with typical EEG findings and neurocognitive regression.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Management Strategies for Electrical Status Epilepticus During Sleep
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.
Read the 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:
- epilepsy with different seizure types,
- neuropsychological regression, and
- 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.
- Conditions
- Epilepsy
- Being tested
- corticosteroid
- Keywords
- electrical status epilepticus during slow wave sleep, seizure, cognition, continuous spikes and waves during sleep
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroidDrug
Each patient will be subjected to a one month course of steroids and then re-evaluated
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive ability
Change in cognitive ability in response to steroids and benzodiazepines by IQ assessment using using Standford - Binnet scales version V.
Measured: 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.
Measured: EEG will be done every three months for upto one year after discontinuation of therapy
Secondary outcomes (1)
Change in seizure frequency
Compare the frequency of seizures before the start of treatment and after the start of treatment.
Measured: Measured before and one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startFeb 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randa Abdelbadie Abdelaleem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randa Abdelbadie Abdelaleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251820
- Sponsor's protocol ID
- MSESES
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Strategies for Electrical Status Epilepticus During Sleep
- ClinicalTrials.gov ID
- NCT03251820
- Acronym / sponsor ID
- MSESES
- Conditions
- Epilepsy
- Keywords
- electrical status epilepticus during slow wave sleep, seizure, cognition, continuous spikes and waves during sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Randa Abdelbadie AbdelaleemUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- epilepsy with different seizure types,
- neuropsychological regression, and
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any epileptic patient not presenting with typical EEG findings and neurocognitive regression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corticosteroidEach patient will be subjected to a one month course of steroids and then re-evaluated | Drug | – |
Primary outcome
Cognitive ability
Time frame: 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.
Interictal epileptiform activity
Time frame: 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.
1 secondary outcome
Change in seizure frequency
Time frame: Measured before and one year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
Related trials for Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Randa Abdelbadie Abdelaleem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El - Sayed Kh Abdel - Karim (01060805170, khalilsay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive ability (time frame: IQ measured before treatment and after completing treatment course and then every three months for one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.