Clinical trial NCT01320306: Intracranial Aneurysms and Cognitive Function
Official title: Intracranial Aneurysms and Cognitive Function
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intracranial Aneurysms
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2011-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.


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

Primary outcomes:
measure: Cognitive function
timeFrame: Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.
Secondary outcomes:
measure: Neurological status
timeFrame: Each subject will undergo one clinical assessment of neurological status.
measure: fMRI
timeFrame: A subgroup of patients will participate in a fMRI study once
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Tor Ingebrigtsen, Phd
role: STUDY_CHAIR
References:
citation: 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.
citation: Sandell T, Isaksen J, Bajic R, Ingebrigtsen T. [Treatment of intracranial aneurysms]. Tidsskr Nor Laegeforen. 2005 Aug 25;125(16):2188-91. Norwegian.