Intracranial Aneurysms and Cognitive Function

Intracranial Aneurysms Clinical Trial

Official title:

Intracranial Aneurysms and Cognitive Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01320306
• Other study ID #: 2010/2292-2
• Status: Terminated
• Start date: March 2011
• Est. completion date: January 31, 2012

Study information

• Verified date: May 2012
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: January 31, 2012
• Est. primary completion date: January 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	University of Tromso

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	Neuropsychological Assessment	Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.
Secondary	Neurological status	A clinical examination of neurological status	Each subject will undergo one clinical assessment of neurological status.
Secondary	fMRI	A subgroup of patients will participate in a fMRI study once	A subgroup of patients will participate in a fMRI study once