Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery (FMRINAVMS)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Intracranial Arteriovenous Malformations |
Procedure: fMRI Navigation AVM resection Procedure: conventional resection |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
- modified Ranking Scale [ Time Frame: six months after operation ] [ Designated as safety issue: Yes ]
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.
- Postoperative complications [ Time Frame: six months after operation ] [ Designated as safety issue: Yes ]Post operative epilepsy seizure, hemorrhage,infarction.
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Yong Cao, MD | 861067096510 ext 100050 | caoyong6@hotmail.com |
| China, Beijing | |
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting |
| Beijing, Beijing, China, 100050 | |
| Contact: Yong Cao, MD 8610 67096510 ext 100050 caoyong6@hotmail.com | |
| Study Chair: | Shuo Wang, MD | Beijing Tiantan Hospital Affiliated to Capital Medical University |
More Information
No publications provided
| Responsible Party: | Dr. Yong Cao, MD, Beijing Tiantan Hospital |
| ClinicalTrials.gov Identifier: | NCT01758211 History of Changes |
| Other Study ID Numbers: | AVM-125-FMRI |
| Study First Received: | December 26, 2012 |
| Last Updated: | March 1, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Beijing Tiantan Hospital:
|
Intracranial Arteriovenous Malformations Functional Magnetic Resonance Imaging Neuronavigation |
Additional relevant MeSH terms:
|
Congenital Abnormalities Arteriovenous Malformations Aneurysm Hemangioma Intracranial Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Neoplasms, Vascular Tissue |
Neoplasms by Histologic Type Neoplasms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Vascular Malformations Nervous System Malformations Intracranial Arterial Diseases |
ClinicalTrials.gov processed this record on May 22, 2013