Intracranial Aneurysms and Cognitive Function

Sponsor
University Hospital of North Norway (Other)
Overall Status
Terminated
CT.gov ID
NCT01320306
Collaborator
University of Tromso (Other)
100
1
11
9.1

Study Details

Study Description

Brief Summary

The prevalence rate of intracranial aneurysms in the adult population is close to 5%. Rupture risk of such aneurysms causing subarachnoid hemorrhage (SAH) can be substantial.Most patients suffering from an aneurysmal SAH are in their mid life, i.e., 30 to 60 years old. Aneurysmal SAH may cause disability and mortality. The present study includes a follow-up study and a cross-sectional fMRI study. The purpose of the follow-up study is to monitor patients receiving prophylactic surgical treatment of their un-ruptured aneurysms to examine whether such treatment is associated with cognitive, psychosocial and/or neurologic sequela. The purpose of the cross-sectional fMRI study is to examine the relationship between memory function and brain activity among SAH patients. Memory impairment is often found among aneurysmal SAH patients. Using fMRI can possibly shed some light on whether such memory impairment may be caused by diffuse cerebral damage or a focal damage at the aneurysm site.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Intracranial Aneurysms and Cognitive Function
    Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Jan 31, 2012
    Actual Study Completion Date :
    Jan 31, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Subarachnoid hemorrhage

    A group of patients suffering aneurismal subarachnoid hemorrhage will participate in a fMRI study.

    Prophylactic surgical treatment of un-ruptured aneurysms

    A retrospective follow-up study of patients who have received prophylactic surgical treatment of un-ruptured aneurysms

    Conservative treatment

    A retrospective follow-up of patients receiving conservative (life stile etc.) treatment of un-ruptured aneurysms.

    Control group of healthy subjects

    Control group of healthy subjects

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive function [Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.]

      Neuropsychological Assessment

    Secondary Outcome Measures

    1. Neurological status [Each subject will undergo one clinical assessment of neurological status.]

      A clinical examination of neurological status

    2. fMRI [A subgroup of patients will participate in a fMRI study once]

      A subgroup of patients will participate in a fMRI study once

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.

    • A subgroup of patients suffering aneurismal subarachnoid hemorrhage.

    Exclusion Criteria:
    • History of earlier cerebrovascular, psychiatric or neurological disease.

    • Age older than 75 years

    • Lack of fluency in Norwegian

    • Alcohol or Substance abuse

    • Aphasia

    • Substantial vision or hearing deficits

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of North Norway Tromsø Norway N-9038

    Sponsors and Collaborators

    • University Hospital of North Norway
    • University of Tromso

    Investigators

    • Study Chair: Tor Ingebrigtsen, Phd, University Hospital of North Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital of North Norway
    ClinicalTrials.gov Identifier:
    NCT01320306
    Other Study ID Numbers:
    • 2010/2292-2
    First Posted:
    Mar 22, 2011
    Last Update Posted:
    Apr 26, 2019
    Last Verified:
    May 1, 2012
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 26, 2019