AneurysmNCT03140020
Cognition and Functional Connectivity After Elective Treatment of Brain Aneurysms
An observational study of Aneurysm, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aneurysm
- What is being tested?
- Clipping and Coiling
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 2 sitesAustria
- Study dates
- 8 Jan 2018to Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated in university hospital setting
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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:
- 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
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Johannes Kepler University Linz, Dept. of Neurosurgery
Linz, Upper Austria, 4020
Medical University Vienna, Dep. of Neurosurgery
Vienna, 1090
About this study
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.
Read the detailed description
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. The investigators' hypothesis is that the functional connectivity of various cognition networks, i.e. cognitive control network, emotion control of cognitive networks, and working memory networks, as assessed by resting state functional magnetic resonance imaging [rsfMRI], can be impaired after uneventful microsurgical and endovascular treatment of unruptured ACoA aneurysms and can be correlated with neuropsychological performance. The investigators propose to investigate 38 patients harboring unruptured ACoA aneurysms and 19 healthy controls over a 36 (until 48) months period. Patients and healthy controls will undergo baseline structural MRI, task fMRI, rsfMRI, and baseline neuropsychological examinations prior as well as 2 months after either microsurgical or endovascular aneurysm treatment or baseline examinations, respectively. Furthermore all subjects will undergo additional neuropsychological examinations 12 months after baseline examination or long-term recovery from microsurgical and endovascular treatment, respectively. The research question is of substantial importance for this patient population, since it is currently incompletely understood how the minor structural brain tissue damages seen after both treatment methods of unruptured ACoA aneurysms translate into the observed neuropsychological deficits - which are often subtle and transient in nature but still insufficiently explained on grounds of morphology and structural connectivity alone. The sensitivity of rsfMRI to depict the functional communication of spatially remote brain regions presents a novel opportunity to investigate these deficits on a whole brain scale by mapping resting state functional connectivity in higher order cognition networks that are thought to be endangered by events related to both microsurgery and embolization. Correlating these data seems promising for several reasons. First, functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders and in ischemic stroke. Ischemic damage to the territories supplied by ACoA perforating arteries is involved in many cases of postoperative neuropsychological impairment after ACoA aneurysm treatment. Second, neuropsychological evaluations have become increasingly incorporated into the standard of care in the postoperative follow-up of cerebral aneurysm patients. RsfMRI could serve as a novel adjunct to neuropsychological outcome assessment. Third, the results could add relevant information to the general perception of the role of frontal lobe and forebrain damage in the pathophysiology of neurocognitive impairment. This could have an impact on neurorehabilitation programs to improve neurocognitive outcome and quality of life in this patient population. Forth, the correlation of validated neuropsychological tests with the functional connectivity rsfMRI data would further enhance the role of rsfMRI in neuroscience and its clinical use.
- Conditions
- Aneurysm
- Being tested
- Clipping, Coiling
- Keywords
- aneurysm, cognition, functional connectivity, frontal lobe function, neuropsychological testing, coiling, clipping
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClippingProcedure or surgery
Also called microsurgical aneurysm clipping
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.
CoilingProcedure or surgery
Also called endovascular treatment of brain aneurysms
Using a catheter technique the aneurysm dome will be filled up with coils to prevent subarachnoidal hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Clipping | |
| 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. Receives: Procedure: Coiling | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prefrontal neuronal functional integration measured with fMRI
Measured: Changes pre- vs. posttreatment after 2 months
Secondary outcomes (2)
Prefrontal executive functioning measured with neuropsychological tests
Measured: Changes pre- vs. posttreatment after 2 months (short-term outcome) and after 12 months (long-term outcome).
Correlation of changes on neuropsychological (executive functioning) and neuronal level (fMRI).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start8 Jan 2018
- Primary completionJul 2019 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Kepler University of Linz
- Responsible party
- Principal investigator, Johannes Kepler University Linz, Johannes Kepler University of Linz
- Investigators
- Andreas Gruber, MD, Principal investigator, Johannes Kepler University of Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140020
- Sponsor's protocol ID
- KLI 597 B27
- Status last verified
- Jan 2018
- First submitted
- 2 May 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and Functional Connectivity After Elective Treatment of Brain Aneurysms
- ClinicalTrials.gov ID
- NCT03140020
- Acronym / sponsor ID
- KLI 597 B27
- Conditions
- Aneurysm
- Keywords
- aneurysm, cognition, functional connectivity, frontal lobe function, neuropsychological testing, coiling, clipping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Johannes Kepler University of Linz
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 4 May 2017 (actual)
- 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 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.
Detailed description
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. The investigators' hypothesis is that the functional connectivity of various cognition networks, i.e. cognitive control network, emotion control of cognitive networks, and working memory networks, as assessed by resting state functional magnetic resonance imaging [rsfMRI], can be impaired after uneventful microsurgical and endovascular treatment of unruptured ACoA aneurysms and can be correlated with neuropsychological performance. The investigators propose to investigate 38 patients harboring unruptured ACoA aneurysms and 19 healthy controls over a 36 (until 48) months period. Patients and healthy controls will undergo baseline structural MRI, task fMRI, rsfMRI, and baseline neuropsychological examinations prior as well as 2 months after either microsurgical or endovascular aneurysm treatment or baseline examinations, respectively. Furthermore all subjects will undergo additional neuropsychological examinations 12 months after baseline examination or long-term recovery from microsurgical and endovascular treatment, respectively. The research question is of substantial importance for this patient population, since it is currently incompletely understood how the minor structural brain tissue damages seen after both treatment methods of unruptured ACoA aneurysms translate into the observed neuropsychological deficits - which are often subtle and transient in nature but still insufficiently explained on grounds of morphology and structural connectivity alone. The sensitivity of rsfMRI to depict the functional communication of spatially remote brain regions presents a novel opportunity to investigate these deficits on a whole brain scale by mapping resting state functional connectivity in higher order cognition networks that are thought to be endangered by events related to both microsurgery and embolization. Correlating these data seems promising for several reasons. First, functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders and in ischemic stroke. Ischemic damage to the territories supplied by ACoA perforating arteries is involved in many cases of postoperative neuropsychological impairment after ACoA aneurysm treatment. Second, neuropsychological evaluations have become increasingly incorporated into the standard of care in the postoperative follow-up of cerebral aneurysm patients. RsfMRI could serve as a novel adjunct to neuropsychological outcome assessment. Third, the results could add relevant information to the general perception of the role of frontal lobe and forebrain damage in the pathophysiology of neurocognitive impairment. This could have an impact on neurorehabilitation programs to improve neurocognitive outcome and quality of life in this patient population. Forth, the correlation of validated neuropsychological tests with the functional connectivity rsfMRI data would further enhance the role of rsfMRI in neuroscience and its clinical use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clipping | – | Procedure: ClippingClipping 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. |
| Coiling | – | Procedure: CoilingCoiling 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in university hospital setting
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClippingAlso: microsurgical aneurysm clippingDuring 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. | Procedure or surgery | Clipping |
| CoilingAlso: endovascular treatment of brain aneurysmsUsing a catheter technique the aneurysm dome will be filled up with coils to prevent subarachnoidal hemorrhage. | Procedure or surgery | Coiling |
Primary outcome
Prefrontal neuronal functional integration measured with fMRI
Time frame: Changes pre- vs. posttreatment after 2 months
2 secondary outcomes
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Andreas Gruber, MD principal investigator
Johannes Kepler University of Linz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, run by Medical University of Vienna at 2 sites in Austria.
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 11 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
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?
Prefrontal neuronal functional integration measured with fMRI (time frame: Changes pre- vs. posttreatment after 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.