Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery
FMRINAVMS
Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2012
CompletedFirst Posted
Study publicly available on registry
January 1, 2013
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 4, 2013
March 1, 2013
2.4 years
December 26, 2012
March 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Ranking Scale
The scale runs from 0-6, running from perfect health without symptoms to death. 0-No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead.
six months after operation
Secondary Outcomes (1)
Postoperative complications
six months after operation
Study Arms (2)
fMRI guided resection of AVM
EXPERIMENTALfMRI Navigation AVM resection in AVM patients
conventional AVM resection
ACTIVE COMPARATORconventional resection of AVM
Interventions
intraoperative fMRI navigation guided resection in AVM patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050, China
Related Publications (4)
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.
PMID: 31379715DERIVEDLi 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.
PMID: 29547081DERIVEDLin 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.
PMID: 27367242DERIVEDZhao 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.
PMID: 25341453DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shuo Wang, MD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 26, 2012
First Posted
January 1, 2013
Study Start
January 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 4, 2013
Record last verified: 2013-03