Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery (FMRINAVMS)
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Arteriovenous Malformations||Procedure: fMRI Navigation AVM resection Procedure: conventional resection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- Postoperative complications [ Time Frame: six months after operation ]Post operative epilepsy seizure, hemorrhage,infarction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758211
|Contact: Yong Cao, MD||861067096510 ext firstname.lastname@example.org|
|Beijing Tiantan Hospital Affiliated to Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Yong Cao, MD 8610 67096510 ext 100050 email@example.com|
|Study Chair:||Shuo Wang, MD||Beijing Tiantan Hospital|