Clinical trial NCT01758211: Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intracranial Arteriovenous Malformations
Keywords: Intracranial Arteriovenous Malformations
Functional Magnetic Resonance Imaging
Neuronavigation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: modified Ranking Scale
timeFrame: six months after operation
Secondary outcomes:
measure: Postoperative complications
timeFrame: six months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.