FMRINAVMS: Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- modified Ranking Scale [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. Dead.
Secondary Outcome Measures
- Postoperative complications [six months after operation]
Post operative epilepsy seizure, hemorrhage,infarction.
Eligibility Criteria
Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital Affiliated to Capital Medical University | Beijing | Beijing | China | 100050 |
Sponsors and Collaborators
- Beijing Tiantan Hospital
Investigators
- Study Chair: Shuo Wang, MD, Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AVM-125-FMRI