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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758211
Recruitment Status : Unknown
Verified March 2013 by Dr. Yong Cao, Beijing Tiantan Hospital.
Recruitment status was:  Recruiting
First Posted : January 1, 2013
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Arteriovenous Malformations Procedure: fMRI Navigation AVM resection Procedure: conventional resection Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial
Study Start Date : January 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: fMRI guided resection of AVM
fMRI Navigation AVM resection in AVM patients
Procedure: fMRI Navigation AVM resection
intraoperative fMRI navigation guided resection in AVM patients

Active Comparator: conventional AVM resection
conventional resection of AVM
Procedure: conventional resection
conventional resection in AVM patients

Primary Outcome Measures :
  1. modified Ranking Scale [ Time Frame: six months after operation ]

    The scale runs from 0-6, running from perfect health without symptoms to death. 0-No symptoms.

    1. No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. Moderate disability. Requires some help, but able to walk unassisted.
    4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. Dead.

Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: six months after operation ]
    Post operative epilepsy seizure, hemorrhage,infarction.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01758211

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Contact: Yong Cao, MD 861067096510 ext 100050

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China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, MD    8610 67096510 ext 100050   
Sponsors and Collaborators
Beijing Tiantan Hospital
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Study Chair: Shuo Wang, MD Beijing Tiantan Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Yong Cao, MD, Beijing Tiantan Hospital Identifier: NCT01758211    
Other Study ID Numbers: AVM-125-FMRI
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013
Keywords provided by Dr. Yong Cao, Beijing Tiantan Hospital:
Intracranial Arteriovenous Malformations
Functional Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases