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Awake Intraoperative Language Mapping and Chinese Probabilistic Map Construction

Primary Purpose

Glioma

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Intraoperative direct cortical electrical stimulation

Intraoperative direct subcortical electrical stimulation

About this trial

This is an interventional prevention trial for Glioma focused on measuring Awake surgery, Direct cortical stimulation, Language mapping, Glioma

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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);
Parietal lobe, which divided into inferior parietal lobule (BA40- supramarginal gyrus, BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1, BA2, BA3);
Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21);
Insular lobe.

Exclusion Criteria:

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

Sites / Locations

Zhongshan Hospital Affiliated to Fudan University
Huashan Hospital Affiliated to Fudan University
Huashan Hospital North, Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Direct electrical stimulation

Arm Description

Intraoperative direct cortical electrical stimulation or intraoperative direct subcortical electrical stimulation on language or language-associate areas, and the participants' after-discharge activity would be monitored. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.

Outcomes

Primary Outcome Measures

Incidence rate of postoperative language deficits

Language deficits were considered when the participant presents with aphasia or severe dysphasia measured by standardized Aphasia Battery of Chinese (ABC, a Chinese version of Western Aphasia Battery) having the Aphasia Quotient (AQ) less than 50 (where lower values represent a worse outcome).

Secondary Outcome Measures

Location of positive sites in cortical mapping

Positive stimulation of the language area was assumed when the participant exhibited counting interruption, errors during object naming, language confusion or other language problems induced by DES. Positive stimulation of the motion area was assumed when movements of the contralateral limb, face, lip or tongue were induced by DES, with the concurrent recording of an electromyogram. Positive stimulation affecting the sensation area was assumed when an abnormal feeling was induced by DES in the contralateral limb, face, lip or tongue. The locations of positive sites will be recorded by neuro-navigation system.

Incidence rate of intraoperative epilepsy induced by direct cortical stimulation

A strip electrode would be placed tangentially over the central sulcus to monitor cortical seizure activity or after-discharge during intraoperative DCS. And the participant would be closely observed for involuntarily shaking or twitching. Any shaking, twitching or after-discharge during monitor would considered as epileptic event. All epileptic events will be recorded and DES will be terminated for the participant.

Extent of resection

Extent of resection (EOR) based on early postoperative MRI obtained within 72h after surgery. Gross total resection (GTR) was defined as the complete disappearance of all enhancing lesions (T1WI) for HGG and the complete disappearance of all nonenhancing (T2WI FLAIR) lesions for LGG. The EOR were quantitatively volumetric analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas, and stratified as: GTR, 100% resection; subtotal resection ≥ 90% resection, partial resection ≥ 70% resection, biopsy, resection ≥98% for overall survival advantage (HGG) and resection ≥90% for overall survival advantage (LGG).

Full Information

NCT ID

NCT03641391

First Posted

August 14, 2018

Last Updated

August 19, 2018

Sponsor

Huashan Hospital

Collaborators

Shanghai Zhongshan Hospital, Huashan Hospital North, Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03641391

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2018 (Anticipated)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

Collaborators

Shanghai Zhongshan Hospital, Huashan Hospital North, Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma

Keywords

Awake surgery, Direct cortical stimulation, Language mapping, Glioma

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Direct electrical stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Intraoperative direct cortical electrical stimulation

Intervention Description

Intraoperative direct electrical stimulation on language or language-associate cortex, was performed using a 5-mm wide bipolar electrode with a pulse frequency of 60 Hz and an amplitude of 1.5 to 6 milliamperage. The somatosensory evoked potential was recorded with a 6-contact subdural strip electrode. If after-discharge activity indicated that the stimulation current was too high, the current amplitude was decreased by 0.5 to 1 milliamperage. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.

Intervention Type

Procedure

Intervention Name(s)

Intraoperative direct subcortical electrical stimulation

Intervention Description

Intraoperative direct electrical stimulation on language or language-associate subcortical pathways, was performed using a biphasic square-wave pulse delivered at 60 Hz with a current amplitude ranging from 1.5 to 10 milliamperage. The somatosensory evoked potential was recorded with a 6-contact subdural strip electrode. If after-discharge activity indicated that the stimulation current was too high, the current amplitude was decreased by 0.5 to 1 milliamperage. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.

Primary Outcome Measure Information:

Title

Incidence rate of postoperative language deficits

Description

Time Frame

The first month and the third month after surgery

Secondary Outcome Measure Information:

Title

Location of positive sites in cortical mapping

Description

Time Frame

During surgery

Title

Incidence rate of intraoperative epilepsy induced by direct cortical stimulation

Description

Time Frame

During surgery

Title

Extent of resection

Description

Time Frame

Within 72h after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals aged 14-70 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated malignant glioma; Individuals with gliomas with bodies involving in dominate side language area(see appendix 1); Individuals with the preoperative assessment that radiological radically should be achieved; Individuals who are cooperative and well tolerated with awake craniotomy; Individuals presents with good communicate and explanation preoperatively; 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: 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); Parietal lobe, which divided into inferior parietal lobule (BA40- supramarginal gyrus, BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1, BA2, BA3); Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21); Insular lobe. Exclusion Criteria: Individuals with age < 14 years or > 70 years; Individuals presents with impaired cognitive function or unstable mental status; Individuals has higher intracranial pressure, sleep apnea syndrome, difficult airway or morbid obesity, claustrophobia, uncontrolled coughing, uncontrolled seizures or inability to stay still etc.; Recurrent gliomas after surgery (except needle biopsy); Primary gliomas with history of radiotherapy or chemotherapy; Renal insufficiency or hepatic insufficiency; History of malignant tumors at any body site; Tumors of the midline, basal ganglia, cerebellum, or brain stem; Inability or unwilling to give informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinsong Wu, MD

Phone

86-021-52887200

wjsongc@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Junfeng Lu, MD

Phone

86-021-52887200

hlujf@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsong Wu, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dongxiao Zhuang, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tianming Qiu, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Junfeng Lu, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Zhongshan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Zhu, MD

Phone

86-021-64041990

First Name & Middle Initial & Last Name & Degree

Wei Zhu, MD

Facility Name

Huashan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinsong Wu, MD

Phone

86-021-52887200

wjsongc@126.com

First Name & Middle Initial & Last Name & Degree

Junfeng Lu, MD

Phone

86-021-52887200

hlujf@126.com

First Name & Middle Initial & Last Name & Degree

Jinsong Wu, MD

First Name & Middle Initial & Last Name & Degree

Dongxiao Zhuang, MD

First Name & Middle Initial & Last Name & Degree

Tianming Qiu, MD

First Name & Middle Initial & Last Name & Degree

Junfeng Lu, MD

First Name & Middle Initial & Last Name & Degree

Jie Zhang, MD

First Name & Middle Initial & Last Name & Degree

Bin Wu, BS

First Name & Middle Initial & Last Name & Degree

Yanming Zhu, BS

Facility Name

Huashan Hospital North, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201907

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liusong Yang, MD

First Name & Middle Initial & Last Name & Degree

Liusong Yang, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Please refer to the principle investigator for participants' data.

Citations:

PubMed Identifier

24970097

Citation

Tate MC, Herbet G, Moritz-Gasser S, Tate JE, Duffau H. Probabilistic map of critical functional regions of the human cerebral cortex: Broca's area revisited. Brain. 2014 Oct;137(Pt 10):2773-82. doi: 10.1093/brain/awu168. Epub 2014 Jun 25.

Results Reference

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PubMed Identifier

18172171

Citation

Sanai N, Mirzadeh Z, Berger MS. Functional outcome after language mapping for glioma resection. N Engl J Med. 2008 Jan 3;358(1):18-27. doi: 10.1056/NEJMoa067819.

Results Reference

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PubMed Identifier

26894457

Citation

Chang EF, Breshears JD, Raygor KP, Lau D, Molinaro AM, Berger MS. Stereotactic probability and variability of speech arrest and anomia sites during stimulation mapping of the language dominant hemisphere. J Neurosurg. 2017 Jan;126(1):114-121. doi: 10.3171/2015.10.JNS151087. Epub 2016 Feb 19.

Results Reference

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PubMed Identifier

25848923

Citation

Duffau H. Stimulation mapping of white matter tracts to study brain functional connectivity. Nat Rev Neurol. 2015 May;11(5):255-65. doi: 10.1038/nrneurol.2015.51. Epub 2015 Apr 7.

Results Reference

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PubMed Identifier

26351094

Citation

Wu J, Lu J, Zhang H, Zhang J, Yao C, Zhuang D, Qiu T, Guo Q, Hu X, Mao Y, Zhou L. Direct evidence from intraoperative electrocortical stimulation indicates shared and distinct speech production center between Chinese and English languages. Hum Brain Mapp. 2015 Dec;36(12):4972-85. doi: 10.1002/hbm.22991. Epub 2015 Sep 9.

Results Reference

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PubMed Identifier

25190682

Citation

Wu J, Lu J, Zhang H, Zhang J, Mao Y, Zhou L. Probabilistic map of language regions: challenge and implication. Brain. 2015 Mar;138(Pt 3):e337. doi: 10.1093/brain/awu247. Epub 2014 Sep 4. No abstract available.

Results Reference

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PubMed Identifier

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Citation

Nakai Y, Jeong JW, Brown EC, Rothermel R, Kojima K, Kambara T, Shah A, Mittal S, Sood S, Asano E. Three- and four-dimensional mapping of speech and language in patients with epilepsy. Brain. 2017 May 1;140(5):1351-1370. doi: 10.1093/brain/awx051.

Results Reference

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PubMed Identifier

25978714

Citation

Breshears JD, Molinaro AM, Chang EF. A probabilistic map of the human ventral sensorimotor cortex using electrical stimulation. J Neurosurg. 2015 Aug;123(2):340-9. doi: 10.3171/2014.11.JNS14889. Epub 2015 May 15.

Results Reference

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PubMed Identifier

23850046

Citation

Lu J, Wu J, Yao C, Zhuang D, Qiu T, Hu X, Zhang J, Gong X, Liang W, Mao Y, Zhou L. Awake language mapping and 3-Tesla intraoperative MRI-guided volumetric resection for gliomas in language areas. J Clin Neurosci. 2013 Sep;20(9):1280-7. doi: 10.1016/j.jocn.2012.10.042. Epub 2013 Jul 10.

Results Reference

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PubMed Identifier

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Citation

Ritaccio AL, Brunner P, Schalk G. Electrical Stimulation Mapping of the Brain: Basic Principles and Emerging Alternatives. J Clin Neurophysiol. 2018 Mar;35(2):86-97. doi: 10.1097/WNP.0000000000000440.

Results Reference

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Awake Intraoperative Language Mapping and Chinese Probabilistic Map Construction

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