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Comprehensive Endovascular and Open Surgical Management of Cerebral Arteriovenous Malformations
Published on: October 20, 2017
Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised
Bing Zhao1, Yong Cao1, Yuanli Zhao1
1Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University; Center of stroke, Beijing institute for brain disorders; Beijing Key Laboratory of Translational Medicine for Cerebraovascular Disease; China National Clinical Research Center for Neurological Diseases, Beijing, China.
Introduction:
Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial.
Methods And Analysis:
The study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery.
Ethics And Dissemination:
The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media.
Trial Registration Number:
ClinicalTrials.gov NCT01758211.
Insights
This randomized trial investigates functional MRI (fMRI)-guided microsurgery for intracranial arteriovenous malformations (AVMs). It aims to determine if fMRI guidance improves surgical outcomes and patient safety compared to standard microsurgery.
Area of Science:
- Neurosurgery
- Neuroradiology
- Clinical Trials
Background:
- Intracranial arteriovenous malformations (AVMs) present significant morbidity and mortality risks.
- Surgical treatment of AVMs, especially those in eloquent locations, remains high-risk despite advances in microsurgery.
- Functional MRI (fMRI) shows potential for preoperative AVM evaluation in preliminary studies.
Purpose of the Study:
- To evaluate the utility and efficacy of fMRI-guided microsurgery for intracranial AVMs.
- To compare outcomes between standard microsurgery and fMRI-guided microsurgery in a large patient cohort.
- To assess the safety and effectiveness of fMRI-guided AVM treatment.
Main Methods:
- A prospective, randomized controlled clinical trial enrolling 600 patients.
- Patients randomized 1:1 to standard microsurgery or fMRI-guided microsurgery.
- fMRI mapping of eloquent cortex for AVMs in the guided group; outcomes assessed using modified Rankin Scale (mRS) at multiple intervals.
Main Results:
- This section is to be filled after the study is completed and data is analyzed.
Conclusions:
- This section is to be filled after the study is completed and data is analyzed.

