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Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

This study is currently recruiting participants.
Verified November 2017 by George KC Wong, Chinese University of Hong Kong
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038193
First Posted: December 23, 2009
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong
  Purpose
This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Condition Intervention
Cognitive Dysfunction Other: Cognitive assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Resource links provided by NLM:


Further study details as provided by George KC Wong, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Cognitive dysfunction [ Time Frame: 3 and 12 months ]
    Montreal Cognitive Assessment


Secondary Outcome Measures:
  • Neurological Outcome [ Time Frame: 3 and 12 months ]
    Modified Rankin Scale

  • Generic Quality of Life [ Time Frame: 3 and 12 months ]
    ShortForm36(SF-36)

  • Activity of Daily Living [ Time Frame: 3 and 12 months ]
    Barthel Index

  • Disease-specific Quality of Life [ Time Frame: 3 and 12 months ]
    Stroke-specific-QOL

  • Functional Outcome [ Time Frame: 3 and 12 months ]
    Functional Independent Measure (FIM)


Estimated Enrollment: 600
Study Start Date: March 2009
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
aSAH patients
Cognitive assessment
Other: Cognitive assessment
Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.
Other Name: Cognition

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Aneurysmal subarachnoid hemorrhage patients
Criteria

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
  Contacts and Locations
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): NCT01038193


Contacts
Contact: George KC Wong (852) 26321316
Contact: Shirley Chiu (852) 26322624

Locations
China, Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, China, 852
Contact: George KC Wong    (852)35052624      
Contact: Carol Chan    (852)35051316      
Principal Investigator: George KC Wong         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: George KC Wong Division of Neurosurgery, CUHK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01038193     History of Changes
Other Study ID Numbers: GW004
First Submitted: December 22, 2009
First Posted: December 23, 2009
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by George KC Wong, Chinese University of Hong Kong:
Cognition, subarachnoid hemorrhage.

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Cognitive Dysfunction
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders