ZOOMit-fMRI Identifies Motor Functional Cortex
The Application of ZOOMit-fMRI to Identify Motor Functional Cortex
1 other identifier
observational
60
1 country
1
Brief Summary
This study was designed to collect a series of patients with gliomas which were involved in motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI and ZOOMit-fMRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJanuary 16, 2019
January 1, 2019
5.9 years
March 16, 2017
January 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The accurate rate for hand motor cortex localization with BOLD-fMRI and ZOOMit-fMRI.
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.
From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.
Study Arms (2)
BOLD-fMRI
Identifying the motor functional cortex in glioma patients with BOLD-fMRI.
ZOOMit-fMRI
Identifying the motor functional cortex in glioma patients with ZOOMit-fMRI.
Eligibility Criteria
All patients with gliomas which are closed to motor area (including primary motor area, premotor area and supplementary area), treated by awake craniotomy and intraoperative brain mapping
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100005, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2017
First Posted
March 27, 2017
Study Start
February 1, 2016
Primary Completion
January 1, 2022
Study Completion
January 1, 2025
Last Updated
January 16, 2019
Record last verified: 2019-01