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Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery (FMRINAVMS)

Primary Purpose

Intracranial Arteriovenous Malformations

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
fMRI Navigation AVM resection
conventional resection
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Arteriovenous Malformations focused on measuring Intracranial Arteriovenous Malformations, Functional Magnetic Resonance Imaging, Neuronavigation

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fMRI guided resection of AVM

conventional AVM resection

Arm Description

fMRI Navigation AVM resection in AVM patients

conventional resection of AVM

Outcomes

Primary Outcome Measures

modified Ranking Scale
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
Post operative epilepsy seizure, hemorrhage,infarction.

Full Information

First Posted
December 26, 2012
Last Updated
March 1, 2013
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01758211
Brief Title
Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery
Acronym
FMRINAVMS
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriovenous Malformations
Keywords
Intracranial Arteriovenous Malformations, Functional Magnetic Resonance Imaging, Neuronavigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fMRI guided resection of AVM
Arm Type
Experimental
Arm Description
fMRI Navigation AVM resection in AVM patients
Arm Title
conventional AVM resection
Arm Type
Active Comparator
Arm Description
conventional resection of AVM
Intervention Type
Procedure
Intervention Name(s)
fMRI Navigation AVM resection
Intervention Description
intraoperative fMRI navigation guided resection in AVM patients
Intervention Type
Procedure
Intervention Name(s)
conventional resection
Intervention Description
conventional resection in AVM patients
Primary Outcome Measure Information:
Title
modified Ranking Scale
Description
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.
Time Frame
six months after operation
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Post operative epilepsy seizure, hemorrhage,infarction.
Time Frame
six months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, MD
Phone
861067096510
Ext
100050
Email
caoyong6@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Cao, MD
Phone
8610 67096510
Ext
100050
Email
caoyong6@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31379715
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.
Results Reference
derived
PubMed Identifier
29547081
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. 2018 Mar 16;130(1):286-301. doi: 10.3171/2017.8.JNS17854.
Results Reference
derived
PubMed Identifier
27367242
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.
Results Reference
derived
PubMed Identifier
25341453
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.
Results Reference
derived

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Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery

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