Rolandic Epilepsy Genomewide Association International Study
NCT ID: NCT03547050
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
210 participants
OBSERVATIONAL
2018-06-01
2023-06-30
Brief Summary
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Detailed Description
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We know that RE has a genetic basis and we recently discovered the genetic cause of the EEG pattern seen in RE. The goal of REGAIN is to now find the genetic basis for susceptibility to seizures and the associated symptoms above. Our hope is to be able to improve diagnosis and understand why each child with RE is different, and perhaps point us towards new treatments that are more effective and have fewer side effects.
We will compare the genetic code of 3,000 children with RE against a similar number of people not affected by epilepsy. With the proposed large sample of participants, we will be able to pinpoint the exact changes that might lead to seizures or attention problems for example. Learning the genetic basis for these problems will deepen our understanding of the mechanisms and lead to new treatments or cures.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Patients diagnosed with RE
People who meet the eligibility requirements and have been diagnosed with rolandic epilepsy.
Blood draw
Participation includes one visit for one blood draw per recruited patient. 10-20ml peripheral venous blood will be taken from the antecubital fossa. The DNA from the blood sample will then be extracted and resequenced for analysis.
Controls
People without a lifetime history of seizures.
Existing samples
Control DNA samples will be used that have been previously acquired in other studies.
Interventions
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Blood draw
Participation includes one visit for one blood draw per recruited patient. 10-20ml peripheral venous blood will be taken from the antecubital fossa. The DNA from the blood sample will then be extracted and resequenced for analysis.
Existing samples
Control DNA samples will be used that have been previously acquired in other studies.
Eligibility Criteria
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Inclusion Criteria
* Age of first afebrile seizure 3-12 years
* Seizures comprising focal sensorimotor seizures affecting the vocal tract and face, with or without involvement of the arm
* Predominant sleep-related seizures
* EEG interictal centro-temporal spikes with normal background
2. Current age 6-25 years
Exclusion Criteria
2. Normal EEG or abnormal background features on EEG
3. Known structural causes (stroke, tuberous sclerosis, infection, post-infectious or metabolic)
4. Primary diagnosis of autism or global learning disability
5. Focal central neurological deficit on clinical exam,
6. Unable to provide informed consent
7. Unable to provide blood sample
6 Years
25 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Cardiff University
OTHER
The Hospital for Sick Children
OTHER
Hospital JP Garrahan
OTHER_GOV
Aghia Sophia Children's Hospital of Athens
OTHER
Hospital Mutua de Terrassa
OTHER
Seattle Children's Hospital
OTHER
Hasbro Children's Hospital
OTHER
Columbia University
OTHER
King's College London
OTHER
Responsible Party
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Locations
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Columbia University Medical Center
New York, New York, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Seattle Children's Hospital
Seattle, Washington, United States
Dr. Juan P. Garrahan Children's Hospital
Buenos Aires, , Argentina
Hospital for Sick Kids
Toronto, Ontario, Canada
Aghia Sophia Children's Hospital of Athens
Athens, , Greece
Sicilian Epilepsy Network
Catania, , Italy
Commissione Genetica Lega Italiana contro l'Epilepssia
Roma, , Italy
Hospital Mutua de Terrassa
Barcelona, , Spain
Cardiff University School of Medicine
Cardiff, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Swansea University College of Medicine
Swansea, , United Kingdom
Countries
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Related Links
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Childhood Epilepsy website
Other Identifiers
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TWF 164-3020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
229844
Identifier Type: -
Identifier Source: org_study_id
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