ZOOMit-fMRI Identifies Motor Functional Cortex

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03091270
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Neurosurgical Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gliomas

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

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International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing, 100005

Site Contact

Tao Jiang, MD and PhD

taojiang1964@163.com

+86-010-67021832

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