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Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms

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ClinicalTrials.gov Identifier: NCT03494608
Recruitment Status : Unknown
Verified May 2018 by Jun Wang, Xuanwu Hospital, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
West China Hospital
Tang-Du Hospital
Information provided by (Responsible Party):
Jun Wang, Xuanwu Hospital, Beijing

Brief Summary:
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.

Condition or disease
Intracranial Aneurysm

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms: a Multi-center Prospective Cohort Study
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. the Incidence of cognitive dysfunction at 6 months after operation [ Time Frame: 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).


Secondary Outcome Measures :
  1. the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation [ Time Frame: 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.

  2. the difference in the percentage of patients with HDMA score ≥14 before operation and 6 months after operation [ Time Frame: 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.

  3. 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 [ Time Frame: 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.

  4. the tendency of SF-36 scores before operation, 3 months after operation, and 6 months after operation [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital
Criteria

Inclusion Criteria:

  1. 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.;
  2. Patients who live independent with minimal care support, mRS score ≤3 points;
  3. Age > 14 years old;
  4. Han ethnicity, Right handed, can complete the test;
  5. Patient or family agrees to sign informed consent.

Exclusion Criteria:

  1. Other cerebrovascular diseases,such as ischemic stroke, arteriovenous malformation, etc;
  2. With an unexplained subarachnoid hemorrhage;
  3. History of Neurological disease surgery;
  4. Previous psychiatric and dementia history that cannot communicate with other people;
  5. Patients who refused to follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494608


Contacts
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Contact: Jun Wang, Master (86)010-83198899 ext 8639 wangj229@126.com

Sponsors and Collaborators
Xuanwu Hospital, Beijing
West China Hospital
Tang-Du Hospital
Investigators
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Study Chair: Jun Wang, Master Xuanwu Hospital, Beijing
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Responsible Party: Jun Wang, Chief nurse of Neurosurgery Department, professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03494608    
Other Study ID Numbers: UIACGF
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Wang, Xuanwu Hospital, Beijing:
cognitive function
quality of life
anxiety
depression
neurological function
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Depression
Behavioral Symptoms
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases