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

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ClinicalTrials.gov Identifier: NCT01758211
Recruitment Status : Unknown
Verified March 2013 by Dr. Yong Cao, Beijing Tiantan Hospital.
Recruitment status was:  Recruiting
First Posted : January 1, 2013
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE December 26, 2012
First Posted Date  ICMJE January 1, 2013
Last Update Posted Date March 4, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2012)
modified Ranking Scale [ Time Frame: six months after operation ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2012)
Postoperative complications [ Time Frame: six months after operation ]
Post operative epilepsy seizure, hemorrhage,infarction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery
Official Title  ICMJE Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Arteriovenous Malformations
Intervention  ICMJE
  • Procedure: fMRI Navigation AVM resection
    intraoperative fMRI navigation guided resection in AVM patients
  • Procedure: conventional resection
    conventional resection in AVM patients
Study Arms  ICMJE
  • Experimental: fMRI guided resection of AVM
    fMRI Navigation AVM resection in AVM patients
    Intervention: Procedure: fMRI Navigation AVM resection
  • Active Comparator: conventional AVM resection
    conventional resection of AVM
    Intervention: Procedure: conventional resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 31, 2012)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01758211
Other Study ID Numbers  ICMJE AVM-125-FMRI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Yong Cao, Beijing Tiantan Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beijing Tiantan Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shuo Wang, MD Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP