- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03140020
Cognition and Functional Connectivity After Elective Treatment of Brain Aneurysms
The aim of this proposal is to investigate the effects of uneventful microsurgical and endovascular treatment of unruptured saccular non-giant anterior communicating artery [ACoA] aneurysms on resting state functional connectivity levels of higher order cognitive networks and to correlate the connectivity levels of these networks with neuropsychological performance and functional outcome.
This study compares two treatment groups and one control group.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical University Vienna, Dep. of Neurosurgery
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Johannes Kepler University Linz, Dept. of Neurosurgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Intervention Groups:
Inclusion criteria
- Male or female patients aged > 18 years
- Microsurgical or endovascular treatment of unruptured, saccular, non giant ACoA aneurysm
- Right-handedness
- Compliance (the patients have to be able to lay motionless in a 3 Tesla MR scanner and to cooperate with the examiner during the examination)
- Willingness and competence to sign informed consent form
- German native speaker
Exclusion criteria
- Ruptured ACoA aneurysm
- Previous history of intracranial hemorrhage or serious head injury
- Non-saccular aneurysm [i.e. dissecting, fusiform, mycotic, traumatic]
- Psychiatric or neuropsychological impairment prior to aneurysm treatment
- Current use of any psychotropic drugs except aneurysm treatment related medication
- Severe visual or auditory impairment
- Current pregnancy or breast feeding
- Metallic implants [other than aneurysm clips or coils detailed in the Ethics section] or other contraindications to MRI
Healthy controls:
Inclusion criteria
- Male or female subjects aged > 18 years
- Right-handedness
- Compliance [the patients have to be able to lay motionless in a 3 Tesla MR scanner and to cooperate with the examiner during the examination]
- Willingness and competence to sign informed consent form
- German native speaker
Exclusion criteria
- Major concurrent or previous medical or neurological illness
- Major concurrent or previous psychiatric Axis I disorder according to DSM-5
- Clinically significant abnormal values in laboratory screening or general physical examination
- Current use of any psychotropic drugs
- Previous history of intracranial hemorrhage, serious head injury
- Previous or current substance abuse [except nicotine and caffeine]
- Severe visual or auditory impairment
- Current pregnancy or breast-feeding
- Metallic implants or other contraindications to MRI
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Clipping
Clipping of an aneurysm of the anterior communicating artery - A titan clip will be placed round the aneurysm neck to exclude the aneurysm from the bloodflow and prevent fatal subarachnoidal hemorrhage.
Patients will undergo baseline structural MRI, task fMRI, rsfMRI, and baseline neuropsychological examinations prior as well as 2 months after microsurgical aneurysm treatment.
Furthermore the patients will undergo additional neuropsychological examinations 12 months after long-term recovery from microsurgical treatment.
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During the microsurgical operation a titan clip will be placed round the aneurysm neck to exclude the aneurysm from the bloodflow and prevent fatal subarachnoidal hemorrhage.
Other Names:
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Coiling
Coiling of an aneurysm of the anterior communicating artery - Using a catheter technique the aneurysm dome will be filled up with coils to prevent subarachnoidal hemorrhage.
Patients will undergo baseline structural MRI, task fMRI, rsfMRI, and baseline neuropsychological examinations prior as well as 2 months after endovascular aneurysm treatment.
Furthermore the patients will undergo additional neuropsychological examinations 12 months after long-term recovery from endovascular treatment.
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Using a catheter technique the aneurysm dome will be filled up with coils to prevent subarachnoidal hemorrhage.
Other Names:
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Healthy Controls
Healthy controls will undergo baseline structural MRI, task fMRI, rsfMRI, and baseline neuropsychological examinations prior as well as 2 months after baseline examinations.
Furthermore all subjects will undergo additional neuropsychological examinations 12 months after baseline examination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Prefrontal neuronal functional integration measured with fMRI
Time Frame: Changes pre- vs. posttreatment after 2 months
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Changes pre- vs. posttreatment after 2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Prefrontal executive functioning measured with neuropsychological tests
Time Frame: Changes pre- vs. posttreatment after 2 months (short-term outcome) and after 12 months (long-term outcome).
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Changes pre- vs. posttreatment after 2 months (short-term outcome) and after 12 months (long-term outcome).
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Correlation of changes on neuropsychological (executive functioning) and neuronal level (fMRI).
Time Frame: Changes pre- vs. posttreatment after 2 months measured with fMRI correlated with changes in neuropsychological tests after 2 months (short-term outcome) and after 12 months (long-term outcome).
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Changes pre- vs. posttreatment after 2 months measured with fMRI correlated with changes in neuropsychological tests after 2 months (short-term outcome) and after 12 months (long-term outcome).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreas Gruber, MD, Johannes Kepler University of Linz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLI 597 B27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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