Cognition and Functional Connectivity After Elective Treatment of Brain Aneurysms

NCT03140020 | Unknown

• 1 other identifier: KLI 597 B27
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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 these networks with neuropsychological performance and functional outcome. This study compares two treatment groups and one control group.

Conditions

Aneurysm

Keywords

aneurysm; cognition; functional connectivity; frontal lobe function; neuropsychological testing; coiling; clipping

Outcome Measures

Primary Outcomes (1)

• Prefrontal neuronal functional integration measured with fMRI

  Changes pre- vs. posttreatment after 2 months

Secondary Outcomes (2)

• Prefrontal executive functioning measured with neuropsychological tests

  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).

  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).

Study Arms (3)

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.

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.

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.

Interventions

Clipping PROCEDURE

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.

Also known as: microsurgical aneurysm clipping

Clipping

Coiling PROCEDURE

Using a catheter technique the aneurysm dome will be filled up with coils to prevent subarachnoidal hemorrhage.

Also known as: endovascular treatment of brain aneurysms

Coiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in university hospital setting

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• Major concurrent or previous medical or neurological illness

Sponsors & Collaborators

• Medical University of Vienna: lead
• Johannes Kepler University of Linz: collaborator

Study Sites (2)

Johannes Kepler University Linz, Dept. of Neurosurgery

Linz, Upper Austria, 4020, Austria

Location

Medical University Vienna, Dep. of Neurosurgery

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas Gruber, MD

  Johannes Kepler University of Linz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Prof.Dr. Andreas Gruber

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: January 8, 2018
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2021
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)