Intracranial AneurysmNCT03494608
Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms
An observational study of Intracranial Aneurysm, run by Xuanwu Hospital, Beijing.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- May 2018to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Keywords
- cognitive function, quality of life, anxiety, depression, neurological function
- Medical subject headings
- Intracranial Aneurysm, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: the 6th month after operation of the patient inclusion in the study
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study startMay 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Tang-Du Hospital
- Responsible party
- Principal investigator, Jun Wang, Xuanwu Hospital, Beijing
- Investigators
- Jun Wang, Master, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494608
- Sponsor's protocol ID
- UIACGF
- Status last verified
- May 2018
- First submitted
- 3 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03494608
- Acronym / sponsor ID
- UIACGF
- Conditions
- Intracranial Aneurysm
- Keywords
- cognitive function, quality of life, anxiety, depression, neurological function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- West China Hospital, Tang-Du Hospital
- Study start
- May 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
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 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 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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Wang, Master study chair
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang, Master ((86)010-83198899 ext. 8639, wangj229@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Incidence of cognitive dysfunction at 6 months after operation (time frame: the 6th month after operation of the patient inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.