Clincosm LogoSign in Get a demo

Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT01038193
Collaborator
(none)
600
Enrollment
1
Location
190
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive assessment

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 Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage
Study Start Date :
Mar 1, 2009
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive dysfunction [3 and 12 months]

      Montreal Cognitive Assessment

    Secondary Outcome Measures

    1. Neurological Outcome [3 and 12 months]

      Modified Rankin Scale

    2. Generic Quality of Life [3 and 12 months]

      ShortForm36(SF-36)

    3. Activity of Daily Living [3 and 12 months]

      Barthel Index

    4. Disease-specific Quality of Life [3 and 12 months]

      Stroke-specific-QOL

    5. Functional Outcome [3 and 12 months]

      Functional Independent Measure (FIM)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong Hong Kong China 852

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George KC Wong, Professor (Clinical), Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT01038193
    Other Study ID Numbers:
    • GW004
    First Posted:
    Dec 23, 2009
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by George KC Wong, Professor (Clinical), Chinese University of Hong Kong
    Cognition, subarachnoid hemorrhage.
    Additional relevant MeSH terms:
    Subarachnoid Hemorrhage
    Hemorrhage
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Jan 27, 2021