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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fMRI guided resection of AVM | Experimental | fMRI Navigation AVM resection in AVM patients |
|
| conventional AVM resection | Active Comparator | conventional resection of AVM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI Navigation AVM resection | Procedure | intraoperative fMRI navigation guided resection in AVM patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| modified Ranking Scale | The scale runs from 0-6, running from perfect health without symptoms to death. 0-No symptoms.
| six months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Post operative epilepsy seizure, hemorrhage,infarction. | six months after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao, MD | Contact | 861067096510 | 100050 | caoyong6@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuo Wang, MD | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31379715 | Derived | Li M, Jiang P, Guo R, Liu Q, Yang S, Wu J, Cao Y, Wang S. A Tractography-Based Grading Scale of Brain Arteriovenous Malformations Close to the Corticospinal Tract to Predict Motor Outcome After Surgery. Front Neurol. 2019 Jul 17;10:761. doi: 10.3389/fneur.2019.00761. eCollection 2019. | |
| 29547081 | Derived | Li D, Jiao YM, Wang L, Lin FX, Wu J, Tong XZ, Wang S, Cao Y. Surgical outcome of motor deficits and neurological status in brainstem cavernous malformations based on preoperative diffusion tensor imaging: a prospective randomized clinical trial. J Neurosurg. 2019 Jan 1;130(1):286-301. doi: 10.3171/2017.8.JNS17854. Epub 2018 Mar 16. |
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| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| conventional resection | Procedure | conventional resection in AVM patients |
|
| 27367242 | Derived | Lin F, Jiao Y, Wu J, Zhao B, Tong X, Jin Z, Cao Y, Wang S. Effect of functional MRI-guided navigation on surgical outcomes: a prospective controlled trial in patients with arteriovenous malformations. J Neurosurg. 2017 Jun;126(6):1863-1872. doi: 10.3171/2016.4.JNS1616. Epub 2016 Jul 1. |
| 25341453 | Derived | Zhao B, Cao Y, Zhao Y, Wu J, Wang S. Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial. BMJ Open. 2014 Oct 23;4(10):e006618. doi: 10.1136/bmjopen-2014-006618. |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |