Intracranial Aneurysms and Cognitive Function

NCT01320306 | Terminated DMC

• 1 other identifier: 2010/2292-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  Neuropsychological Assessment

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

Secondary Outcomes (2)

• Neurological status

  Each subject will undergo one clinical assessment of neurological status.

• fMRI

  A subgroup of patients will participate in a fMRI study once

Study Arms (4)

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, N-9038, Norway

Location

Related Publications (2)

• 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.

  PMID: 18818402 BACKGROUND

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

  PMID: 16138132 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tor Ingebrigtsen, Phd

  University Hospital of North Norway

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: January 31, 2012
• Study Completion: January 31, 2012
• Last Updated: April 26, 2019

Record last verified: 2012-05

Locations

NO (1)