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Cognitive DysfunctionNCT01038193

Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

An observational study of Cognitive Dysfunction, run by Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Dysfunction
What is being tested?
Cognitive assessment
How many people
600 participants
Where
1 siteChina
Study dates
1 Mar 2009to 31 Oct 2023
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 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Aneurysmal subarachnoid hemorrhage patients

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Prince of Wales Hospital

    Hong Kong, Hong Kong, 852

Other trials in China

About this study

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

Read the 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.

Being tested
Cognitive assessment
Keywords
Cognition, subarachnoid hemorrhage.
Medical subject headings
Cognitive Dysfunction, Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive assessmentOther

    Also called Cognition

    Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.

Study groups in NCT01038193
Study groupRoleWhat they receive
aSAH patientsCognitive assessment
Receives: Other: Cognitive assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive dysfunction

    Montreal Cognitive Assessment

    Measured: 3 and 12 months

Secondary outcomes (5)

  1. Neurological Outcome

    Modified Rankin Scale

    Measured: 3 and 12 months

  2. Generic Quality of Life

    ShortForm36(SF-36)

    Measured: 3 and 12 months

  3. Activity of Daily Living

    Barthel Index

    Measured: 3 and 12 months

  4. Disease-specific Quality of Life

    Stroke-specific-QOL

    Measured: 3 and 12 months

  5. Functional Outcome

    Functional Independent Measure (FIM)

    Measured: 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2009 (estimated)
  2. Study start1 Mar 2009
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

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
Case only
Time perspective
Prospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01038193
Sponsor's protocol ID
GW004
Status last verified
Feb 2024
First submitted
22 Dec 2009
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wong GK, Lam SW, Wong A, Ngai K, Mok V, Poon WS. Early Cognitive Domain Deficits in Patients with Aneurysmal Subarachnoid Hemorrhage Correlate with Functional Status. Acta Neurochir Suppl. 2016;122:129-32. doi: 10.1007/978-3-319-22533-3_26.

    PubMed 27165892

  • Wong GK, Wong A, Zee BC, Poon WS, Chan MT, Gin T, Siu DY, Mok VC. Cognitive outcome in acute simvastatin treatment for aneurysmal subarachnoid hemorrhage: A propensity matched analysis. J Neurol Sci. 2015 Nov 15;358(1-2):58-61. doi: 10.1016/j.jns.2015.08.013. Epub 2015 Aug 12.

    PubMed 26285662

  • Chu AC, Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Cognitive impairment in aneurysmal subarachnoid hemorrhage patients with delayed cerebral infarction: prevalence and pattern. Acta Neurochir Suppl. 2015;120:303-6. doi: 10.1007/978-3-319-04981-6_51.

    PubMed 25366641

  • Wong GK, Lam SW, Wong A, Lai M, Siu D, Poon WS, Mok V. MoCA-assessed cognitive function and excellent outcome after aneurysmal subarachnoid hemorrhage at 1 year. Eur J Neurol. 2014 May;21(5):725-30. doi: 10.1111/ene.12363. Epub 2014 Jan 28.

    PubMed 24471651

  • Wong GK, Lam SW, Wong A, Mok V, Siu D, Ngai K, Poon WS. Early MoCA-assessed cognitive impairment after aneurysmal subarachnoid hemorrhage and relationship to 1-year functional outcome. Transl Stroke Res. 2014 Apr;5(2):286-91. doi: 10.1007/s12975-013-0284-z. Epub 2013 Sep 7.

    PubMed 24323708

  • Wong GK, Lam SW, Ngai K, Wong A, Poon WS, Mok V. Development of a short form of Stroke-Specific Quality of Life Scale for patients after aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2013 Dec 15;335(1-2):204-9. doi: 10.1016/j.jns.2013.09.033. Epub 2013 Oct 2.

    PubMed 24120271

  • Wong GK, Lam SW, Ngai K, Wong A, Siu D, Poon WS, Mok V; Cognitive Dysfunction after Aneurysmal Subarachnoid Hemorrhage Investigators. Cognitive domain deficits in patients with aneurysmal subarachnoid haemorrhage at 1 year. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1054-8. doi: 10.1136/jnnp-2012-304517. Epub 2013 Apr 20.

    PubMed 23606736

  • Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Comparison of montreal cognitive assessment and mini-mental state examination in evaluating cognitive domain deficit following aneurysmal subarachnoid haemorrhage. PLoS One. 2013;8(4):e59946. doi: 10.1371/journal.pone.0059946. Epub 2013 Apr 3.

    PubMed 23573223

  • Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.

    PubMed 22851612

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Dysfunction, run by Chinese University of Hong Kong at 1 site in China.

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 2 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: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive dysfunction (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01038193, which also lists 9 linked publications.

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 21 Feb 2024.

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