Intracranial Aneurysms and Cognitive Function

April 24, 2019 updated by: University Hospital of North Norway
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, N-9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.
Neuropsychological Assessment
Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological status
Time Frame: Each subject will undergo one clinical assessment of neurological status.
A clinical examination of neurological status
Each subject will undergo one clinical assessment of neurological status.
fMRI
Time Frame: A subgroup of patients will participate in a fMRI study once
A subgroup of patients will participate in a fMRI study once
A subgroup of patients will participate in a fMRI study once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

University of Tromso

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

January 31, 2012

Study Completion (Actual)

January 31, 2012

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/2292-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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