Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

February 19, 2024 updated by: George KC Wong, Chinese University of Hong Kong
This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to recruit a total of 240 aneurysmal subarachnoid haemorrhage patients. The schedule for neuropsychological and functional assessments will be phased in at the second to third week, the third month, and the twelve months after the initial haemorrhage.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: George KC Wong
  • Phone Number: (852) 26321316

Study Contact Backup

  • Name: Shirley Chiu
  • Phone Number: (852) 26322624

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 852
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aneurysmal subarachnoid hemorrhage patients

Description

Inclusion criteria

  1. Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology
  2. Admission within 96 hours of ictus
  3. Aged between 21 and 75 years
  4. A speaker of Chinese (Mandarin or Cantonese)
  5. Informed consent from patients or their legally acceptable representatives

Exclusion criteria

  1. History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm
  2. History of neurosurgical operation prior to ictus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aSAH patients
Cognitive assessment
Other: Cognitive assessment
Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.
Other Names:
  • Cognition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive dysfunction
Time Frame: 3 and 12 months
Montreal Cognitive Assessment
3 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological Outcome
Time Frame: 3 and 12 months
Modified Rankin Scale
3 and 12 months
Generic Quality of Life
Time Frame: 3 and 12 months
ShortForm36(SF-36)
3 and 12 months
Activity of Daily Living
Time Frame: 3 and 12 months
Barthel Index
3 and 12 months
Disease-specific Quality of Life
Time Frame: 3 and 12 months
Stroke-specific-QOL
3 and 12 months
Functional Outcome
Time Frame: 3 and 12 months
Functional Independent Measure (FIM)
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: George KC Wong, Division of Neurosurgery, CUHK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimated)

December 23, 2009

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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