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

Intracranial Arteriovenous Malformations Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758211
• Other study ID #: AVM-125-FMRI
• Status: Recruiting
• Phase: Phase 3
• First received: December 26, 2012
• Last updated: March 1, 2013
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2013
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, MD
• Phone: 861067096510
• Email: caoyong6[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six months after operation	Yes
Secondary	Postoperative complications	Post operative epilepsy seizure, hemorrhage,infarction.	six months after operation	Yes