An observational study in Intracranial Aneurysm, sponsored by Xuanwu Hospital, Beijing. Status unknown. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by Xuanwu Hospital, Beijing · Observational
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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.
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.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 350 is above the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
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the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the Incidence of cognitive dysfunction at 6 months after operation
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).
Time frame: the 6th month after operation of the patient inclusion in the study
the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
36-item short form health survey(SF-36)
Time frame: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
No study locations are listed for this record.
Start is estimated for May 2018; primary completion for Feb 2020, 21 months later.
Of 67 non-industry observational studies under Intracranial Aneurysm, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 145. This study's planned 21 months is below that.
Counting every sponsor, half of 104 studies reached it within 46 months; a quarter within 36 and three quarters within 145.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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