Awake Intraoperative Language Mapping and Chinese Probabilistic Map Construction

NCT03641391 | Unknown

• 1 other identifier: KY2012-009
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Glioma

Keywords

Awake surgery; Direct cortical stimulation; Language mapping; Glioma

Outcome Measures

Primary Outcomes (1)

• 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).

  The first month and the third month after surgery

Secondary Outcomes (3)

• Location of positive sites in cortical mapping

  During surgery

• Incidence rate of intraoperative epilepsy induced by direct cortical stimulation

  During surgery

• Extent of resection

  Within 72h after surgery

Study Arms (1)

Direct electrical stimulation

EXPERIMENTAL

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.

Procedure: Intraoperative direct cortical electrical stimulation; Procedure: Intraoperative direct subcortical electrical stimulation

Interventions

Intraoperative direct cortical electrical stimulation PROCEDURE

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.

Direct electrical stimulation

Intraoperative direct subcortical electrical stimulation PROCEDURE

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.

Direct electrical stimulation

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Huashan Hospital North, Fudan University: collaborator

Study Sites (3)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Huashan Hospital North, Fudan University

Shanghai, Shanghai Municipality, 201907, China

Location

Related Publications (10)

• 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.

  PMID: 24970097 BACKGROUND

• 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.

  PMID: 18172171 BACKGROUND

• 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.

  PMID: 26894457 BACKGROUND

• 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.

  PMID: 25848923 BACKGROUND

• 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.

  PMID: 26351094 BACKGROUND

• 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.

  PMID: 25190682 BACKGROUND

• 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.

  PMID: 28334963 BACKGROUND

• 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.

  PMID: 25978714 BACKGROUND

• 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.

  PMID: 23850046 BACKGROUND

• 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.

  PMID: 29499015 BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jinsong Wu, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Dongxiao Zhuang, MD

  Huashan Hospital

  STUDY DIRECTOR

• Tianming Qiu, MD

  Huashan Hospital

  STUDY DIRECTOR

• Junfeng Lu, MD

  Huashan Hospital

  STUDY DIRECTOR

Central Study Contacts

Jinsong Wu, MD

CONTACT

86-021-52887200; wjsongc@126.com

Junfeng Lu, MD

CONTACT

86-021-52887200; hlujf@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

CN (3)