Intracranial AneurysmsNCT01320306
Intracranial Aneurysms and Cognitive Function
An observational study of Intracranial Aneurysms, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysms
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to 31 Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.
- A subgroup of patients suffering aneurismal subarachnoid hemorrhage.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Neuropsychological Assessment
Measured: Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.
Secondary outcomes (2)
Neurological status
A clinical examination of neurological status
Measured: Each subject will undergo one clinical assessment of neurological status.
fMRI
A subgroup of patients will participate in a fMRI study once
Measured: A subgroup of patients will participate in a fMRI study once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completion31 Jan 2012
- Study completion31 Jan 2012
Why it stopped: Could not be implemented
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Tor Ingebrigtsen, Phd, Study chair, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320306
- Sponsor's protocol ID
- 2010/2292-2
- Status last verified
- May 2012
- First submitted
- 18 Mar 2011
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18818402Sandell T, Isaksen J, Bajic R, Ingebrigtsen T. [Treatment of intracranial aneurysms]. Tidsskr Nor Laegeforen. 2005 Aug 25;125(16):2188-91. Norwegian.
PubMed 16138132
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Aneurysms and Cognitive Function
- ClinicalTrials.gov ID
- NCT01320306
- Acronym / sponsor ID
- 2010/2292-2
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not be implemented
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Mar 2011
- Primary completion
- 31 Jan 2012 (actual)
- Study completion
- 31 Jan 2012 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.
- A subgroup of patients suffering aneurismal subarachnoid hemorrhage.
Key exclusion criteria (6 listed)
- History of earlier cerebrovascular, psychiatric or neurological disease.
- Age older than 75 years
- Lack of fluency in Norwegian
- Alcohol or Substance abuse
- Aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function
Time frame: Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.
Neuropsychological Assessment
2 secondary outcomes
Neurological status
Time frame: Each subject will undergo one clinical assessment of neurological status.
fMRI
Time frame: A subgroup of patients will participate in a fMRI study once
Results and safety
The study was stopped early (reason given: Could not be implemented). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 18818402Isaksen 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.
- Background: PubMed 16138132Sandell T, Isaksen J, Bajic R, Ingebrigtsen T. [Treatment of intracranial aneurysms]. Tidsskr Nor Laegeforen. 2005 Aug 25;125(16):2188-91. Norwegian.
Related trials for Intracranial Aneurysms
Active, not recruitingPhase 2
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Cerebral Aneurysm
RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingObservational study
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Intracranial Aneurysm
Recruiting
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Aneurysm, Aneurysm, Intracranial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tor Ingebrigtsen, Phd study chair
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Could not be implemented). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.