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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Natacha Forthoffer
- Telefonnummer: 03.83.85.20.77
- E-mail: n.forthoffer@chru-nancy.fr
Studiesteder
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Nancy, Frankrig, 54000
- Rekruttering
- Department of neurology - Hospital of Nancy
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Kontakt:
- Forthoffer Natacha
- E-mail: n.forthoffer@chru-nancy.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of impaired cognitive functions according to the cognitive domain assessed
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Louis Maillard, Pr, Professor of Neurology
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- n°2020-A00404-35
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Kliniske forsøg med Epilepsi
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Boston Children's HospitalRekrutteringEpilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdomForenede Stater