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Intracranial Aneurysms and Cognitive Function

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01320306
First received: March 18, 2011
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Intracranial Aneurysms

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Intracranial Aneurysms and Cognitive Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks. ] [ Designated as safety issue: No ]
    Neuropsychological Assessment


Secondary Outcome Measures:
  • Neurological status [ Time Frame: Each subject will undergo one clinical assessment of neurological status. ] [ Designated as safety issue: No ]
    A clinical examination of neurological status

  • fMRI [ Time Frame: A subgroup of patients will participate in a fMRI study once ] [ Designated as safety issue: No ]
    A subgroup of patients will participate in a fMRI study once


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.A subgroup of patients suffering aneurismal subarachnoid hemorrhage.

University Hospital of North Norway

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320306

Locations
Norway
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
  More Information

Publications:

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01320306     History of Changes
Other Study ID Numbers: 2010/2292-2
Study First Received: March 18, 2011
Last Updated: May 11, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013