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.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Natacha Forthoffer
- 電話番号：03.83.85.20.77
- メール：n.forthoffer@chru-nancy.fr
研究場所
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Nancy、フランス、54000
- 募集
- Department of neurology - Hospital of Nancy
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コンタクト：
- Forthoffer Natacha
- メール：n.forthoffer@chru-nancy.fr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Proportion of impaired cognitive functions according to the cognitive domain assessed
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Louis Maillard, Pr、Professor of Neurology
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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