Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery

Study Overview
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Brief Summary
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Little is known about the effect of fMRI navigation in the intracranial arteriovenous malformation surgery. The investigators aim to perform a multicenter prospective randomized single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain arteriovenous malformation surgery.

Detailed Description
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Intracranial arteriovenous malformations (AVMs) are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without an intervening normal capillary bed. Surgical removal is thought as a major treatment option for AVMs. However, compared with stereotaxic radiosurgery and endovascular embolization, microsurgery of AVMs is regarded with high mortality and morbidity, particular for high level classification AVMs . Blood oxygen level dependent fMRI can be used to mapping the motor and language regions of the brain noninvasively. It has been one of the most advanced functional imaging techniques and it has quickly grown to be a vital tool for clinical and cognitive neuroscience research. Many clinical researches have been reported about the utility of fMRI in brain tumor surgery. However, the effect of fMRI navigation for neurofunction protection in the intracranial arteriovenous malformation surgery was unclear. We aim to perform a multicenter prospective randomized single -blind clinical trial to assess the safety and effect of fMRI navigation in the intracranial AVMs surgery. We hypothesize that application of blood oxygen level dependent fMRI is able to improve long term prognosis of patients.

Official Title
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Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial

Conditions
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Intracranial Arteriovenous Malformations

Intervention / Treatment
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* Procedure: fMRI Navigation AVM resection
* Procedure: conventional resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of intracranial AVM by DSA/CT/MRI Age from 12-60 years Be suitable for microsurgery treatment All patients are able to cooperate with the fMRI examination All patients gave written informed consent Exclusion Criteria: Patients with age < 12 years or > 60 years Various conditions unable to meet the indications for microsurgery treatment Intracranial hemorrhage need emergency surgery Patients can not cooperate with fMRI examination

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fMRI guided resection of AVM<br>fMRI Navigation AVM resection in AVM patients | Procedure: fMRI Navigation AVM resection<br>* intraoperative fMRI navigation guided resection in AVM patients<br>|
| Active Comparator: conventional AVM resection<br>conventional resection of AVM | Procedure: conventional resection<br>* conventional resection in AVM patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Ranking Scale | The scale runs from 0-6, running from perfect health without symptoms to death. 0-No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead. | six months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Post operative epilepsy seizure, hemorrhage,infarction. | six months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Arteriovenous Malformations, Functional Magnetic Resonance Imaging, Neuronavigation