GliomaNCT05019196
fMRI Study of Functional Reorganization in Glioma Patients
An observational study of Glioma, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- GE 3.0T MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Fifty patients with right-handed low-grade glioma who met the inclusion and exclusion criteria were included
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioma
- Being tested
- GE 3.0T MRI
- Keywords
- low-grade glioma; fMRI; function reorganization
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE 3.0T MRIDevice
using GE 3.0T MRI to obtain anatomical and functional MR images and DTI images
| Study group | Role | What they receive |
|---|---|---|
| fMRI，functional reorganization, functional connectivity, functional rating scale | low-grade glioma patients healthy controls Receives: Device: GE 3.0T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of functional connections between cerebral hemispheric regions
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
Measured: 2021.12.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Niu, PhD, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019196
- Sponsor's protocol ID
- 2018SF-113
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marusyk A, Almendro V, Polyak K. Intra-tumour heterogeneity: a looking glass for cancer? Nat Rev Cancer. 2012 Apr 19;12(5):323-34. doi: 10.1038/nrc3261.
PubMed 22513401Stupp R, Brada M, van den Bent MJ, Tonn JC, Pentheroudakis G; ESMO Guidelines Working Group. High-grade glioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii93-101. doi: 10.1093/annonc/mdu050. Epub 2014 Apr 29. No abstract available.
PubMed 24782454Rosler J, Niraula B, Strack V, Zdunczyk A, Schilt S, Savolainen P, Lioumis P, Makela J, Vajkoczy P, Frey D, Picht T. Language mapping in healthy volunteers and brain tumor patients with a novel navigated TMS system: evidence of tumor-induced plasticity. Clin Neurophysiol. 2014 Mar;125(3):526-36. doi: 10.1016/j.clinph.2013.08.015. Epub 2013 Sep 16.
PubMed 24051073Southwell DG, Hervey-Jumper SL, Perry DW, Berger MS. Intraoperative mapping during repeat awake craniotomy reveals the functional plasticity of adult cortex. J Neurosurg. 2016 May;124(5):1460-9. doi: 10.3171/2015.5.JNS142833. Epub 2015 Nov 6.
PubMed 26544767Duffau H. The huge plastic potential of adult brain and the role of connectomics: new insights provided by serial mappings in glioma surgery. Cortex. 2014 Sep;58:325-37. doi: 10.1016/j.cortex.2013.08.005. Epub 2013 Aug 19.
PubMed 24050218Saito T, Muragaki Y, Miura I, Tamura M, Maruyama T, Nitta M, Kurisu K, Iseki H, Okada Y. Functional plasticity of language confirmed with intraoperative electrical stimulations and updated neuronavigation: case report of low-grade glioma of the left inferior frontal gyrus. Neurol Med Chir (Tokyo). 2014;54(7):587-92. doi: 10.2176/nmc.cr.2013-0248. Epub 2014 Feb 28.
PubMed 24584281Duffau H. Lessons from brain mapping in surgery for low-grade glioma: insights into associations between tumour and brain plasticity. Lancet Neurol. 2005 Aug;4(8):476-86. doi: 10.1016/S1474-4422(05)70140-X.
PubMed 16033690Duffau H. Diffuse low-grade gliomas and neuroplasticity. Diagn Interv Imaging. 2014 Oct;95(10):945-55. doi: 10.1016/j.diii.2014.08.001. Epub 2014 Sep 16.
PubMed 25218490Briganti C, Sestieri C, Mattei PA, Esposito R, Galzio RJ, Tartaro A, Romani GL, Caulo M. Reorganization of functional connectivity of the language network in patients with brain gliomas. AJNR Am J Neuroradiol. 2012 Nov;33(10):1983-90. doi: 10.3174/ajnr.A3064. Epub 2012 May 3.
PubMed 22555573Otten ML, Mikell CB, Youngerman BE, Liston C, Sisti MB, Bruce JN, Small SA, McKhann GM 2nd. Motor deficits correlate with resting state motor network connectivity in patients with brain tumours. Brain. 2012 Apr;135(Pt 4):1017-26. doi: 10.1093/brain/aws041. Epub 2012 Mar 8.
PubMed 22408270Desmurget M, Bonnetblanc F, Duffau H. Contrasting acute and slow-growing lesions: a new door to brain plasticity. Brain. 2007 Apr;130(Pt 4):898-914. doi: 10.1093/brain/awl300. Epub 2006 Nov 21.
PubMed 17121742Abd-El-Barr MM, Saleh E, Huang RY, Golby AJ. Effect of disease and recovery on functional anatomy in brain tumor patients: insights from functional MRI and diffusion tensor imaging. Imaging Med. 2013 Aug 1;5(4):333-346. doi: 10.2217/iim.13.40.
PubMed 24660024Tuntiyatorn L, Wuttiplakorn L, Laohawiriyakamol K. Plasticity of the motor cortex in patients with brain tumors and arteriovenous malformations: a functional MR study. J Med Assoc Thai. 2011 Sep;94(9):1134-40.
PubMed 21970205Kosla K, Pfajfer L, Bryszewski B, Jaskolski D, Stefanczyk L, Majos A. Functional rearrangement of language areas in patients with tumors of the central nervous system using functional magnetic resonance imaging. Pol J Radiol. 2012 Jul;77(3):39-45. doi: 10.12659/pjr.883373.
PubMed 23049580Bryszewski B, Pfajfer L, Antosik-Biernacka A, Tybor K, Smigielski J, Zawirski M, Majos A. Functional rearrangement of the primary and secondary motor cortex in patients with primary tumors of the central nervous system located in the region of the central sulcus depending on the histopathological type and the size of tumor: Examination by means of functional magnetic resonance imaging. Pol J Radiol. 2012 Jan;77(1):12-20. doi: 10.12659/pjr.882576.
PubMed 22802861
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study on the Recombination of Brain Motor and Language Function Induced by Glioma
- ClinicalTrials.gov ID
- NCT05019196
- Acronym / sponsor ID
- 2018SF-113
- Conditions
- Glioma
- Keywords
- low-grade glioma; fMRI; function reorganization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI，functional reorganization, functional connectivity, functional rating scale | – | Device: GE 3.0T MRIlow-grade glioma patients healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fifty patients with right-handed low-grade glioma who met the inclusion and exclusion criteria were included
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GE 3.0T MRIusing GE 3.0T MRI to obtain anatomical and functional MR images and DTI images | Device | fMRI，functional reorganization, functional connectivity, functional rating scale |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Results publication: PubMed 22513401Marusyk A, Almendro V, Polyak K. Intra-tumour heterogeneity: a looking glass for cancer? Nat Rev Cancer. 2012 Apr 19;12(5):323-34. doi: 10.1038/nrc3261.
- Results publication: PubMed 24782454Stupp R, Brada M, van den Bent MJ, Tonn JC, Pentheroudakis G; ESMO Guidelines Working Group. High-grade glioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii93-101. doi: 10.1093/annonc/mdu050. Epub 2014 Apr 29. No abstract available.
- Results publication: PubMed 24051073Rosler J, Niraula B, Strack V, Zdunczyk A, Schilt S, Savolainen P, Lioumis P, Makela J, Vajkoczy P, Frey D, Picht T. Language mapping in healthy volunteers and brain tumor patients with a novel navigated TMS system: evidence of tumor-induced plasticity. Clin Neurophysiol. 2014 Mar;125(3):526-36. doi: 10.1016/j.clinph.2013.08.015. Epub 2013 Sep 16.
- Results publication: PubMed 26544767Southwell DG, Hervey-Jumper SL, Perry DW, Berger MS. Intraoperative mapping during repeat awake craniotomy reveals the functional plasticity of adult cortex. J Neurosurg. 2016 May;124(5):1460-9. doi: 10.3171/2015.5.JNS142833. Epub 2015 Nov 6.
- Results publication: PubMed 24050218Duffau H. The huge plastic potential of adult brain and the role of connectomics: new insights provided by serial mappings in glioma surgery. Cortex. 2014 Sep;58:325-37. doi: 10.1016/j.cortex.2013.08.005. Epub 2013 Aug 19.
- Results publication: PubMed 24584281Saito T, Muragaki Y, Miura I, Tamura M, Maruyama T, Nitta M, Kurisu K, Iseki H, Okada Y. Functional plasticity of language confirmed with intraoperative electrical stimulations and updated neuronavigation: case report of low-grade glioma of the left inferior frontal gyrus. Neurol Med Chir (Tokyo). 2014;54(7):587-92. doi: 10.2176/nmc.cr.2013-0248. Epub 2014 Feb 28.
- Results publication: PubMed 16033690Duffau H. Lessons from brain mapping in surgery for low-grade glioma: insights into associations between tumour and brain plasticity. Lancet Neurol. 2005 Aug;4(8):476-86. doi: 10.1016/S1474-4422(05)70140-X.
- Results publication: PubMed 25218490Duffau H. Diffuse low-grade gliomas and neuroplasticity. Diagn Interv Imaging. 2014 Oct;95(10):945-55. doi: 10.1016/j.diii.2014.08.001. Epub 2014 Sep 16.
- Results publication: PubMed 22555573Briganti C, Sestieri C, Mattei PA, Esposito R, Galzio RJ, Tartaro A, Romani GL, Caulo M. Reorganization of functional connectivity of the language network in patients with brain gliomas. AJNR Am J Neuroradiol. 2012 Nov;33(10):1983-90. doi: 10.3174/ajnr.A3064. Epub 2012 May 3.
- Results publication: PubMed 22408270Otten ML, Mikell CB, Youngerman BE, Liston C, Sisti MB, Bruce JN, Small SA, McKhann GM 2nd. Motor deficits correlate with resting state motor network connectivity in patients with brain tumours. Brain. 2012 Apr;135(Pt 4):1017-26. doi: 10.1093/brain/aws041. Epub 2012 Mar 8.
- Results publication: PubMed 17121742Desmurget M, Bonnetblanc F, Duffau H. Contrasting acute and slow-growing lesions: a new door to brain plasticity. Brain. 2007 Apr;130(Pt 4):898-914. doi: 10.1093/brain/awl300. Epub 2006 Nov 21.
- Results publication: PubMed 24660024Abd-El-Barr MM, Saleh E, Huang RY, Golby AJ. Effect of disease and recovery on functional anatomy in brain tumor patients: insights from functional MRI and diffusion tensor imaging. Imaging Med. 2013 Aug 1;5(4):333-346. doi: 10.2217/iim.13.40.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Niu, PhD study director
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Niu, PhD (0086-13619266896, niuchen.xjtu@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of functional connections between cerebral hemispheric regions (time frame: 2021.12.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019196, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.