Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy (PRECONISE)
A prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (AED). Multiple factors exist and interact in the same patient. Cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). These factors in turn influence cognitive abilities in a triangular and bidirectional relationship. In addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (AED, surgery) and etiology also have an impact on cognitive performances. The burden of these factors differs from patient to another and must be determined individually. Longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time.
The main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of AED with healthy subjects matched on age, sex, manual laterality and socio-educational level. But also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Natacha Forthoffer
- Telefoonnummer: 03.83.85.20.77
- E-mail: n.forthoffer@chru-nancy.fr
Studie Locaties
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Nancy, Frankrijk, 54000
- Werving
- Department of neurology - Hospital of Nancy
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Contact:
- Forthoffer Natacha
- E-mail: n.forthoffer@chru-nancy.fr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria (patients):
- Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
- Person aged 16 and over
- For minor patients: the non-opposition of the parental authority holders
- Newly diagnosed epileptic patient who had never taken antiepileptic drugs.
Inclusion Criteria (normal controls):
- Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
- For minor participants: the non-opposition of the parental authority holders
- Person aged 16 and over.
Exclusion Criteria (patients):
- Person of full age who are subject to a legal protection measure or who are unable to express their consent
- Person with a progressive brain injury
- Person who regularly use psychoactive substances (cannabis, alcohol, etc.)
- Patients who started an antiepileptic treatment before the neuropsychological assessment.
Exclusion Criteria (normal controls):
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent
- Person with a neurological (traumatic brain injury, stroke, etc.) and/or psychiatric (mental illness, depression, etc.) history.
- People who regularly use psychoactive substances (cannabis, alcohol, etc.).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Newly diagnosed epileptic patients
Newly diagnosed epileptic patients who have never be treated by antiepileptic drugs and who have no psychiatric (mental illness) and/or evolutive neurological history and for minor patients the non-opposition of the parental authority holders.
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Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests.
There are questionnaires to assess mood disorders, anxiety and cognitive reserve.
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Normal controls
Matched (on age, gender, socio-educationnal level and manual laterality) healthy controls who have no psychiatric (depression, mental illness) and/or neurological (stroke, traumatic brain injury, etc.) history and for minor patients the non-opposition of the parental authority holders.
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Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests.
There are questionnaires to assess mood disorders, anxiety and cognitive reserve.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.
Tijdsspanne: Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30)
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Neuropsychological assessment:
Questionnaires:
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Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Proportion of impaired cognitive functions according to the cognitive domain assessed
Tijdsspanne: Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment)
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Participants are assessed 6 times Neuropsychological assessment:
Questionnaires:
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Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Louis Maillard, Pr, Professor of Neurology
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- n°2020-A00404-35
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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