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Prospective Study of Awake Intraoperative Language Mapping and Construction of Chinese Probabilistic Map Based on Direct Electrical Stimulation
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.
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.
Age
14 - 70 years
Sex
ALL
Healthy Volunteers
No
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Huashan Hospital North, Fudan University
Shanghai, Shanghai Municipality, China
Start Date
September 1, 2018
Primary Completion Date
December 1, 2023
Completion Date
December 1, 2023
Last Updated
August 22, 2018
300
ESTIMATED participants
Intraoperative direct cortical electrical stimulation
PROCEDURE
Intraoperative direct subcortical electrical stimulation
PROCEDURE
Lead Sponsor
Huashan Hospital
Collaborators
NCT05099003
NCT05839379
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06860594