Clinical trial NCT03641391: Awake Intraoperative Language Mapping and Chinese Probabilistic Map Construction
Official title: Prospective Study of Awake Intraoperative Language Mapping and Construction of Chinese Probabilistic Map Based on Direct Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: Awake surgery
Direct cortical stimulation
Language mapping
Glioma
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Huashan Hospital North, Fudan University
First posted: 2018-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study aims at constructing a Chinese language probabilistic map by awake intraoperative direct electrical stimulation (DES) language mapping. At the same time, the standardization and optimization of awake intraoperative DES parameters will be explored, factors affecting postoperative function morbidity and survival will also be analyzed.

Detailed description: The study aims at constructing a Chinese language probabilistic map by awake intraoperative direct electrical stimulation (DES) language mapping.

The "maximal safe resection" of brain tumor adjacent to language cortex requires precise real-time localization of the intraoperative language cortex.

Awake craniotomy combined with DES to localize language cortex has been carried out for several decades. However, there is yet no unified standard on the specification of its technical parameters. Besides, language probabilistic maps based on DES have been reported by several teams around the world. However these studies were based on the Indo-European language speakers alone. There was one paper published in 2015 by the investigators' group using DES for the Chinese probabilistic map, but it is also a single center study, and the sample size is relatively small.

Awake craniotomy and intraoperative DES for language cortex localization will be used to construct a Chinese probabilistic map in this study. Several common tasks for language mapping (i.e., number counting, picture naming, word reading) will be applied in Chinese speakers. The positive language sites including speech arrest, anomia, alexia, anarthria, dysarthria, semantic paraphasia and phonological paraphasia, spatial negativity and other higher order cognitive function will be identified in individual patients and normalized to the standard brain atlas. The corresponding probabilistic maps will be integrated and generated.

At the same time, the standardization and optimization of awake intraoperative DES parameters will be explored, factors affecting postoperative function morbidity and survival will also be analyzed.

Through this study, the investigators will further popularize individualized awake surgery of glioma in language cortex, improve the extent of tumor resection, protect postoperative language function and improve postoperative quality of life. By constructing this standardized Chinese probabilistic map, the investigators will provide more direct evidence for brain language research.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 14-70 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated malignant glioma;
2. Individuals with gliomas with bodies involving in dominate side language area(see appendix 1);
3. Individuals with the preoperative assessment that radiological radically should be achieved;
4. Individuals who are cooperative and well tolerated with awake craniotomy;
5. Individuals presents with good communicate and explanation preoperatively;
6. All participants gave written informed consent.

Appendix 1. Tumor location in eloquent areas: located in or close to areas of the dominant-hemisphere that associated with motor or language functions, including:

1. Frontal lobe, which divided into inferior frontal gyrus (BA44-Pars opercularis, BA45-Pars triangularis/Broca's area), middle frontal gyrus (BA9, BA46), superior frontal gyrus (BA4, BA6, BA8), primary motor cortex (BA4), premotor cortex (BA6), and supplementary motor area (BA6);
2. Parietal lobe, which divided into inferior parietal lobule (BA40- supramarginal gyrus, BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1, BA2, BA3);
3. Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21);
4. Insular lobe.

Exclusion Criteria:

1. Individuals with age \< 14 years or \> 70 years;
2. Individuals presents with impaired cognitive function or unstable mental status;
3. Individuals has higher intracranial pressure, sleep apnea syndrome, difficult airway or morbid obesity, claustrophobia, uncontrolled coughing, uncontrolled seizures or inability to stay still etc.;
4. Recurrent gliomas after surgery (except needle biopsy);
5. Primary gliomas with history of radiotherapy or chemotherapy;
6. Renal insufficiency or hepatic insufficiency;
7. History of malignant tumors at any body site;
8. Tumors of the midline, basal ganglia, cerebellum, or brain stem;
9. Inability or unwilling to give informed consent.

Primary outcomes:
measure: Incidence rate of postoperative language deficits
timeFrame: The first month and the third month after surgery
Secondary outcomes:
measure: Location of positive sites in cortical mapping
timeFrame: During surgery
measure: Incidence rate of intraoperative epilepsy induced by direct cortical stimulation
timeFrame: During surgery
measure: Extent of resection
timeFrame: Within 72h after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital North, Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jinsong Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Dongxiao Zhuang, MD
role: STUDY_DIRECTOR
affiliation: Huashan Hospital
name: Tianming Qiu, MD
role: STUDY_DIRECTOR
affiliation: Huashan Hospital
name: Junfeng Lu, MD
role: STUDY_DIRECTOR
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