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

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Intracranial Arteriovenous Malformations

Treatments: Procedure: conventional resection; Procedure: fMRI Navigation AVM resection

Study type: Interventional

Funder types: Other

Identifiers

NCT01758211

AVM-125-FMRI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of intracranial AVM by DSA/CT/MRI
2. Age from 12-60 years
3. Be suitable for microsurgery treatment
4. All patients are able to cooperate with the fMRI examination
5. All patients gave written informed consent

Exclusion criteria

1. Patients with age < 12 years or > 60 years
2. Various conditions unable to meet the indications for microsurgery treatment
3. Intracranial hemorrhage need emergency surgery
4. Patients can not cooperate with fMRI examination

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

fMRI guided resection of AVM

Experimental group

Description:

fMRI Navigation AVM resection in AVM patients

Treatment:

Procedure: fMRI Navigation AVM resection

conventional AVM resection

Active Comparator group

Description:

conventional resection of AVM

Treatment:

Procedure: conventional resection