Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms
8 mai 2018 mis à jour par: Jun Wang, Xuanwu Hospital, Beijing
Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms: a Multi-center Prospective Cohort Study
This prospective single-center cohort study aims to identify the incidence of cognitive dysfunction after unruptured aneurysm operation and explore the influencing factors.
The primary end point is the cognitive dysfunction at 6 months after operation.The features of cognitive function, mental status, neurological function recovery, and quality of life of patients with unruptured intracranial aneurysms at different time points would be analyzed.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
This main topics is to identify and screen the patients with unruptured aneurysm who likely to suffer from cognitive dysfunction.
All examinations were administered by a trained neuropsychologist.The assessment of cognitive function and mental state would be performed before operation and 6 months after operation, with the use of Montreal Cognitive Assessment Scale (MoCA) for the cognitive function, the Hamilton Anxiety Scale (HAMA) and the Hamilton Depression Scale (HDMA) tests for the mental state.
The Cognitive dysfunction at 6 months after operation would be the primary end point, and the underlying factors responsible for the declined cognitive function would be analyze.
The assessment of neurological function and quality of life would be performed before operation,3 months after operation and 6 months after operation, with the use of the Modified Rankin Scale(mRS) and the Functional Activities Questionnaire(FAQ) for the neurological function, the Richards-Campbell Sleep Questionnaire(RCSQ) and the 36-item short from health survey(SF-36) tests for the quality of life.
Type d'étude
Observationnel
Inscription (Anticipé)
350
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
14 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital
La description
Inclusion Criteria:
- At least one imaging (CTA / MRI / DSA) study to confirm unruptured intracranial aneurysms for the patients who would undergo surgical treatment for the first time.;
- Patients who live independent with minimal care support, mRS score ≤3 points;
- Age > 14 years old;
- Han ethnicity, Right handed, can complete the test;
- Patient or family agrees to sign informed consent.
Exclusion Criteria:
- Other cerebrovascular diseases，such as ischemic stroke, arteriovenous malformation, etc;
- With an unexplained subarachnoid hemorrhage;
- History of Neurological disease surgery;
- Previous psychiatric and dementia history that cannot communicate with other people;
- Patients who refused to follow up.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the Incidence of cognitive dysfunction at 6 months after operation
Délai: the 6th month after operation of the patient inclusion in the study
|
The Montreal Cognitive Assessment Scale (MoCA) scale contains 8 cognitive domain,11 items and is suitable for assess cognitive function which including: Attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation.. 1 point for each correct answer.
No points if they make any errors.
The total score is 30 points.
For those who have been educated for 12 years or less and the total score of MoCA is less than 30, one point is added to the total MoCA score.
According to the results of MoCA assessment, Patients were divided into two groups: cognitive dysfunction group and cognitive function normal group.
MoCA score ≥26 points suggested normal cognitive function (CN).
|
the 6th month after operation of the patient inclusion in the study
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation
Délai: before operation and the 6th month after operation of the patient inclusion in the study
|
The Hamilton Anxiety Scale (HAMA) scale contains 14 items and is suitable for the adults with anxiety.
Each item is divided into 5 grades evaluated using 0 to 4 scores.
The total scores of HAMA scale can reflect patients' anxious condition to some extent.
The total scores of less than 7 is regarded as no anxiety, 7 or more possible anxiety, 14 or more definite anxiety, 21 or more marked anxiety, 29 or more severe anxiety.
In this study, Anxiety is defined as≥14 points.
|
before operation and the 6th month after operation of the patient inclusion in the study
|
|
the difference in the percentage of patients with HDMA score ≥14 before operation and 6 months after operation
Délai: before operation and the 6th month after operation of the patient inclusion in the study
|
The Hamilton Depression Scale (HAMD) scale contains 24 items and is suitable for the adults with depression.
Each item is divided into 5 grades evaluated using 0 to 4 scores.
The total scores of the HAMD scale can reflect patients' depressive condition to some extent.
The total scores of less than 8 is regarded as no depression, 8 to 16 mild depression, 17 to 24 moderate depression, and more than 24 severe depression.
In this study, Depression is defined as≥14 points.
|
before operation and the 6th month after operation of the patient inclusion in the study
|
|
the tendency of mRS scores and the difference in the percentage of patients with mRS scores 0-3 and 4-6 points before operation, 3 months after operation, and 6 months after operation
Délai: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
|
The Modified Rankin Scale (mRS) is a valid and clinically relevant instrument that is used to assess recovery (death, disability, and dependence) after stroke and is a commonly used outcome measure in SAH studies.
The mRS ranges from 0 (no symptoms) to 6 (death).
Unfavourable outcome in survivors is defined as mRS 3-5.
|
before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
|
|
the tendency of SF-36 scores before operation, 3 months after operation, and 6 months after operation
Délai: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
|
36-item short form health survey(SF-36)
|
before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Jun Wang, Master, Xuanwu Hospital, Beijing
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 mai 2018
Achèvement primaire (Anticipé)
1 février 2020
Achèvement de l'étude (Anticipé)
1 mai 2020
Dates d'inscription aux études
Première soumission
3 avril 2018
Première soumission répondant aux critères de contrôle qualité
3 avril 2018
Première publication (Réel)
11 avril 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 mai 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UIACGF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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