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

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

Tracking Information

• First Submitted Date: December 26, 2012
• First Posted Date: January 1, 2013
• Last Update Posted Date: March 4, 2013
• Study Start Date: January 2013
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: December 31, 2012)

Postoperative complications [ Time Frame: six months after operation ]

Post operative epilepsy seizure, hemorrhage,infarction.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Intracranial Arteriovenous Malformations

Intervention

• Procedure: fMRI Navigation AVM resection
  intraoperative fMRI navigation guided resection in AVM patients
• Procedure: conventional resection
  conventional resection in AVM patients

Study Arms

• 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 *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 31, 2012): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2015
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01758211
• Other Study ID Numbers: AVM-125-FMRI
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr. Yong Cao, Beijing Tiantan Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Beijing Tiantan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Shuo Wang, MD; Beijing Tiantan Hospital

• PRS Account: Beijing Tiantan Hospital
• Verification Date: March 2013