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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

March 18, 2011
May 11, 2012
March 2011
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01320306 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Intracranial Aneurysms and Cognitive Function
Intracranial Aneurysms and Cognitive Function

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.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Intracranial Aneurysms
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01320306
2010/2292-2
Yes
University Hospital of North Norway
University Hospital of North Norway
University of Tromso
Study Chair: Tor Ingebrigtsen, Phd University Hospital of North Norway
University Hospital of North Norway
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP