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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Beijing Tiantan Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT01758211
First received: December 26, 2012
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Intracranial Arteriovenous Malformations
Procedure: fMRI Navigation AVM resection
Procedure: conventional resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Beijing Tiantan Hospital:

Primary Outcome Measures:
  • modified Ranking Scale [ Time Frame: six months after operation ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: six months after operation ] [ Designated as safety issue: Yes ]
    Post operative epilepsy seizure, hemorrhage,infarction.


Estimated Enrollment: 600
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fMRI guided resection of AVM
fMRI Navigation AVM resection in AVM patients
Procedure: fMRI Navigation AVM resection
intraoperative fMRI navigation guided resection in AVM patients
Active Comparator: conventional AVM resection
conventional resection of AVM
Procedure: conventional resection
conventional resection in AVM patients

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

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758211

Contacts
Contact: Yong Cao, MD 861067096510 ext 100050 caoyong6@hotmail.com

Locations
China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, MD    8610 67096510 ext 100050    caoyong6@hotmail.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
Study Chair: Shuo Wang, MD Beijing Tiantan Hospital
  More Information

No publications provided

Responsible Party: Dr. Yong Cao, MD, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT01758211     History of Changes
Other Study ID Numbers: AVM-125-FMRI
Study First Received: December 26, 2012
Last Updated: March 1, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing Tiantan Hospital:
Intracranial Arteriovenous Malformations
Functional Magnetic Resonance Imaging
Neuronavigation

Additional relevant MeSH terms:
Hemangioma
Congenital Abnormalities
Arteriovenous Malformations
Intracranial Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on August 26, 2014