Intracranial Aneurysms and Cognitive Function

NCT ID: NCT01320306

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-01-31

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.

Conditions

Intracranial Aneurysms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Subarachnoid hemorrhage

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

No interventions assigned to this group

Prophylactic surgical treatment of un-ruptured aneurysms

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

No interventions assigned to this group

Conservative treatment

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

No interventions assigned to this group

Control group of healthy subjects

Control group of healthy subjects

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tor Ingebrigtsen, Phd

Role: STUDY_CHAIR

University Hospital of North Norway

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

References

Isaksen JG, Bazilevs Y, Kvamsdal T, Zhang Y, Kaspersen JH, Waterloo K, Romner B, Ingebrigtsen T. Determination of wall tension in cerebral artery aneurysms by numerical simulation. Stroke. 2008 Dec;39(12):3172-8. doi: 10.1161/STROKEAHA.107.503698. Epub 2008 Sep 25.

Reference Type: BACKGROUND

PMID: 18818402 (View on PubMed)

Sandell T, Isaksen J, Bajic R, Ingebrigtsen T. [Treatment of intracranial aneurysms]. Tidsskr Nor Laegeforen. 2005 Aug 25;125(16):2188-91. Norwegian.

Reference Type: BACKGROUND

PMID: 16138132 (View on PubMed)

Other Identifiers

2010/2292-2

Identifier Type: -

Identifier Source: org_study_id