Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial
12 Years
60 Years
Both
Intracranial Arteriovenous Malformations
Trial Information
Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
modified Ranking Scale
Outcome Description:
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.
Outcome Time Frame:
six months after operation
Safety Issue:
Yes
Principal Investigator
Shuo Wang, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Beijing Tiantan Hospital Affiliated to Capital Medical University
Authority:
China: Ministry of Health
Study ID:
AVM-125-FMRI
NCT ID:
NCT01758211
Start Date:
January 2013
Completion Date:
June 2015
Related Keywords:
- Intracranial Arteriovenous Malformations
- Intracranial Arteriovenous Malformations
- Functional Magnetic Resonance Imaging
- Neuronavigation
- Congenital Abnormalities
- Arteriovenous Malformations
- Aneurysm
- Hemangioma
- Intracranial Arteriovenous Malformations
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