Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorImagine Institute
About this trial
Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.
The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Developmental and Epileptic Encephalopathy
Registered with or benefiting from a social security scheme.
Disqualifiers
Opposition of the patient or his/her parents to the re-use of data in the context of this study
Person subject to a safeguard of justice measure
Trial population
Patient diagnosed with developmental encephalopathy and epilepsy.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Patient
Group B: Control patient
Trial outcomes
Primary outcomes
1
Identification of diagnostic and early predictive biomarkers of a neurodevelopmental trajectory with epileptic and developmental encephalopathies
This composite outcome includes multiple diagnostic domains (Clinical, biological, radiological, genetic and electroencephalographic variables)
Time frame
Data 2002-2026Secondary outcomes
1
Identification of patient subgroups presenting the identified biomarkers
To identify patient subgroups, correlation analyses will be carried out to highlight any common clinical, biological, genetic, radiological and electroencephalographic findings.
Time frame
Data 2002-20262
Assessment of patients' quality of life
The SF-12 questionnaire is used to assess quality of life.
Time frame
Data 2002-20263
Assessment of age-related adaptive behavior
To assess the age of adaptive behavior, the Vineland II scale is the reference test.
Time frame
Data 2002-20264
Assessment of behavioral disorders
The CBCL (Child Behaviour Checklist) questionnaire is the reference test for assessing behavioural problems.
Time frame
Data 2002-2026Sponsors and contacts
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Source ClinicalTrials.gov