Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms
8 de maio de 2018 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Antecipado)
350
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
14 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the Incidence of cognitive dysfunction at 6 months after operation
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Jun Wang, Master, Xuanwu Hospital, Beijing
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de maio de 2018
Conclusão Primária (Antecipado)
1 de fevereiro de 2020
Conclusão do estudo (Antecipado)
1 de maio de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
3 de abril de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de abril de 2018
Primeira postagem (Real)
11 de abril de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UIACGF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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