- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03091270
ZOOMit-fMRI Identifies Motor Functional Cortex
The Application of ZOOMit-fMRI to Identify Motor Functional Cortex
Study Overview
Status
Conditions
Detailed Description
Gliomas will lead motor dysfunction when they are involved in motor cortex. However, tumor resection also have risk to lead postoperatively motor function deficits if destroy patients' motor cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' motor cortex locations in order to determine personal operative protocol.
The blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization motor cortex. It shows motor relevant cortex by the change of blood oxygen level when patients cooperate to finish motor tasks. The advantage of BOLD-fMRI includes higher time and spatial resolution, higher sensitivity, non-invasive. However, its accuracy of localization has not been satisfactory because neurovascular uncoupling. The ZOOMit-fMRI is a novel technic which is evolved from conventional BOLD-fMRI to localize motor functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI. That helps to reduce other region of brain interference and elevate accuracy of localizations.
In this study, the investigators plan to enroll 60 patients, whose gliomas are involved in motor cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of motor cortex localization.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100005
- Recruiting
- Beijing Neurosurgical Institute and Beijing Tiantan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
The inclusion criteria were as follows: 1) age ≥ 18 years; 2) no history of surgical treatment or radiotherapy; 3) no contraindication to MRI scanning; 4) agreeable to receive the fMRI scanning and awake craniotomy with DCS.
The exclusion criteria were as follows: 1) basing on the anatomic MRI, the distance from the tumor to the hand-knob area lower than 20 mm; 2) disable to finish the task of clenching fist during fMRI scanning.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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BOLD-fMRI
Identifying the motor functional cortex in glioma patients with BOLD-fMRI.
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ZOOMit-fMRI
Identifying the motor functional cortex in glioma patients with ZOOMit-fMRI.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The accurate rate for hand motor cortex localization with BOLD-fMRI and ZOOMit-fMRI.
Time Frame: From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.
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To illustrate the accurate rate of hand motor cortex localization, the overlap indexes in BOLD-fMRI or ZOOMit-fMRI will be calculated.
The results in BOLD-fMRI and ZOOMit-fMRI will be defined with 300 maximum value voxels via Statistical Parametric Mapping 8 (SPM8) software.
According to the photographs and records of direct cortical stimulation (DCS) during awaken craniotomy, the DCS results will be confirmed as a global region with 5 mm diameter.
Subsequently, we will overlap the BOLD-fMRI/ZOOMit-fMRI and DCS results then calculate the number of voxels overlapping.
In this way, the overlap indexes can be calculated as a ratio between the number of voxels overlapping and the number of total voxels in BOLD-fMRI and ZOOMit-fMRI.
We defined if the overlap index is larger than 0, the localization result is accurate.
In contrast, if the overlap index is equal to zero, the localization result is inaccurate.
Finally, the accurate rate of hand motor cortex localization can be calculated.
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From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSFC-81601452
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