fMRI Study of Functional Reorganization in Glioma Patients

August 19, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

Neuroimaging Study on the Recombination of Brain Motor and Language Function Induced by Glioma

Glioma is an invasive growth, easy to relapse, poor prognosis, great harm to human and society. Studies have shown that gliomas can cause the dynamic reorganization of brain functional areas, affecting the accuracy of surgical resection and the evaluation of long-term efficacy. While, it is difficult to monitor the functional reorganization of glioma in existing studies. The development trend can not effectively predict the outcome of tumor anaplasia and the compensation of brain function, which restricts the accurate tumor resection. In the early stage of this study, functional connectivity analysis was carried out of gliomas in the motor region and showed that the damage of motor functional connectivity on the opposite side of the lesion occurred earlier than that on the same side, suggesting that there may be some rules of how the disease caused functional reorganization. After stroke, the language and motor function will undergo plasticity, causing the functional areas to slowly repair the damaged function. Contrast to stroke, low-grade glioma grows slower, which gives brain more time to adapt to the damage caused by tumor growth, it may cause more functional reorganization. Professor Hugues Duffau's research showed that it is brain plasticity that can effectively explain patients with low-grade gliomas, even in language and motor areas, did not appear obvious dysfunction. Our previous research found there were significant differences in motor functional connectivity between the two hemispheres of the patients between the plasma tumor group and healthy controls. In addition, in the tumor group, the damage of motor connection on the contralateral side of the lesion occurred before on the ipsilateral side. These results suggest that brain function has been remodeled in patients with brain tumors who have not yet exhibited motor impairment. We presume there may be a certain pattern of brain function reorganization caused by low-grade glioma. This study take patients with brain glioma as the research object and adopt a multi-time point experimental design, combining with cortical electrical stimulation and multimodal magnetic resonance imaging data before and after operation, intending to observe the dynamic changes of language and motor function networks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Glioblastoma is the most common malignant tumor of the central nervous system in adults. It is highly invasive, grows rapidly and has a poor prognosis. Brain tumors, whether benign or malignant in nature, take up space in the skull and will follow the tumor. The malignant degree of growth, so that the intracranial pressure increases, thus compression or destruction of brain tissue, leading to central nervous damage, it endangers the life of the patient.

At present, neurosurgery is still the main treatment for craniocerebral tumors. Surgical resection course degree is a determinant of patient survival. Due to individual differences and pathological changes, the effect of causing the variation of the anatomical position of brain functional areas and the generation of intraoperative brain tissue displacement all make it difficult to determine correct functional areas, which is the main reason that affects the accuracy and postoperative effect of surgery.

However, routine MRI scans have difficulty in identifying changes in adjacent functional areas caused by tumors, and is also difficult to define the boundaries of invasive neoplasms. The application of functional magnetic resonance imaging and diffusion tensor imaging enables neurosurgeons not only to be accurate positioning the functional areas, but knowing the functional areas caused by the tumor before neurosurgery, so as to maximize removing the tumor and better protecting important functional areas.

After stroke, the language and motor function will undergo plasticity, causing the language and motor areas to slowly repair the damaged brain function. Contrast to stroke, low-grade glioma grows slower, which gives brain more time to adapt to the damage caused by tumor growth, it may cause more functional reorganization. Professor Hugues Duffau's research, published in the journal Brain, also shows that it is brain plasticity that can effectively explain patients with low-grade gliomas, even in language and motor areas, did not appear obvious dysfunction. Therefore, exploring the brain functional plasticity of low-grade glioma not only facilitates the maximum resection of the tumor, but also help for prediction of postoperative of rehabilitation.

Therefore, taking the patients with brain glioma as the object in this project, combining with intraoperative cortical electrical stimulation and multiple modal magnetic resonance imaging, a multi-time longitudinal study was designed to explore the imaging features of changes in motor and language plasticity in low-grade gliomas.

All images were obtained using a GE3.0T magnetic resonance scanner. 3D-T1FSPGR（ fast spoiled gradient echo）was scanned for anatomical images, T2-weighted single-shot gradient-echo-planae-imaging sequence for functional images. Tak-based fMRI used block design mode (e.g. ABAB mode) with 30s resting state (A) and 30s hand movement task (B) alternating, the whole task process has a total of 6 resting states, 5 tasks state composition. All patients and healthy controls were instructed to repeatedly play each visual stimulus with open and close hand. All the subjects were trained on a specific exercise task before the scans, to ensure that the task is fully understood and that you are able to cooperate carefully to complete the scan. Language tasks use the block design paradigm. The equation is control-task-control last for 5min30s with 30s interval.

In this study, the subjects looked at the "+" symbol on the screen and lay quietly on the exam bed performing three language tasks. All the patients were trained to better cooperate with the subjects. To avoid head movement displacement during scanning, patients are required to speak as softly as possible that is whisper. Furthermore，derect electric stimulus was conducted in every patient. If the distance between functional areas and the positive target of electrical stimulation was less than 1cm, the results of fMRI and electrical considered were considered to be consistent. As for functional rating scale, the standard chinese version of the Quality of Life Inventory EORTC QLQ-C30 (3.0) was used to assess the preoperative quality of life of patients with brain tumors; KPS( Karnofsky Performance Status Scale）was used to evaluate physiological function; Mini-Mental State Examination (MMSE) was used for clinical screening of cognitive impairment, evaluate the patients' interpretation, spatial orientation, memory and computation, linguistic naming and reading ability.

Correlation analysis was conducted between the fMRI data processing results and functional scale score, to build the brain structure - function correlation models and explore different stages of low-grade glioma recombination mode of functional areas.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fifty patients with right-handed low-grade glioma who met the inclusion and exclusion criteria were included

Description

Inclusion Criteria:

  • All cases underwent no treatment or surgery before examination;
  • Can cooperate to complete routine MRI, fMRI, DTI, and rfMRI were required and the image quality was graded the value of analysis;
  • All cases were confirmed by craniotomy and pathology;
  • Right-handed;
  • Mass lesion located in the left dominant hemisphere
  • single lesion;
  • No chronic diseases such as hypertension and diabetes

Exclusion Criteria:

  • History of neurological diseases;
  • Previous history of brain trauma accompanied by consciousness disorder;
  • Before scanning 6, a history of long-term use of psychoactive substances such as alcohol and drug within one month;
  • Obviously mentally handicapped;
  • magnetic resonance (NMR) check for contraindications;
  • Family history of neuropsychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fMRI，functional reorganization, functional connectivity, functional rating scale
low-grade glioma patients healthy controls
Device: GE 3.0T MRI
using GE 3.0T MRI to obtain anatomical and functional MR images and DTI images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of functional connections between cerebral hemispheric regions
Time Frame: 2021.12.1
This study selected the functional activation regions of the patients' own motor or language tasks were used as seed points for the functional connections of complex brain networks analysis. Each region of interest is defined as a sphere with a radius of 6mm for functional connection analysis. Among them, Pearson's correlation coefficient was used as a pairing calculation between brain regions in each patient. Apply the Fisher's r turnZ method is used to improve the normality of the correlation coefficient
2021.12.1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Chen Niu, PhD, The First Affiliated Hospital of Xi 'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018SF-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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