GliomaNCT03641391
Awake Intraoperative Language Mapping and Chinese Probabilistic Map Construction
A study testing Intraoperative direct cortical electrical stimulation and Intraoperative direct subcortical electrical stimulation in people with Glioma, run by Huashan Hospital at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Glioma
- What is being tested?
- Intraoperative direct cortical electrical stimulation and Intraoperative direct subcortical electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2018to 1 Dec 2023
- Phase
- Interventional
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Wei Zhu, MD, 86-021-64041990
Wei Zhu, MD
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Jinsong Wu, MD, 86-021-52887200, wjsongc@126.com
Junfeng Lu, MD, 86-021-52887200, hlujf@126.com
Huashan Hospital North, Fudan University
Shanghai, Shanghai Municipality, 201907
Liusong Yang, MD
Liusong Yang, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioma
- Being tested
- Intraoperative direct cortical electrical stimulation, Intraoperative direct subcortical electrical stimulation
- Keywords
- Awake surgery, Direct cortical stimulation, Language mapping, Glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative direct cortical electrical stimulationProcedure or surgery
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.
Intraoperative direct subcortical electrical stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intraoperative direct cortical electrical stimulation; Procedure: Intraoperative direct subcortical electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The first month and the third month after surgery
Secondary outcomes (3)
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.
Measured: During surgery
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.
Measured: During surgery
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).
Measured: Within 72h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Jinsong Wu, MD, Principal investigator, Huashan HospitalDongxiao Zhuang, MD, Study director, Huashan HospitalTianming Qiu, MD, Study director, Huashan HospitalJunfeng Lu, MD, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641391
- Sponsor's protocol ID
- KY2012-009
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Please refer to the principle investigator for participants' data.
Publications
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.
PubMed 24970097Sanai 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.
PubMed 18172171Chang 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.
PubMed 26894457Duffau 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.
PubMed 25848923Wu 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.
PubMed 26351094Wu 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.
PubMed 25190682Nakai 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.
PubMed 28334963Breshears 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.
PubMed 25978714Lu 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.
PubMed 23850046Ritaccio 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.
PubMed 29499015
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Awake Intraoperative Language Mapping and Construction of Chinese Probabilistic Map Based on Direct Electrical Stimulation
- ClinicalTrials.gov ID
- NCT03641391
- Acronym / sponsor ID
- KY2012-009
- Conditions
- Glioma
- Keywords
- Awake surgery, Direct cortical stimulation, Language mapping, Glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Aug 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct electrical stimulation | Experimental | Procedure: Intraoperative direct cortical electrical stimulation, Procedure: Intraoperative direct subcortical electrical stimulationIntraoperative 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. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Intraoperative direct cortical electrical stimulationIntraoperative 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. | Procedure or surgery | Direct electrical stimulation |
| Intraoperative direct subcortical electrical stimulationIntraoperative 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. | Procedure or surgery | Direct electrical stimulation |
Primary outcome
Incidence rate of postoperative language deficits
Time frame: The first month and the third month after surgery
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).
3 secondary outcomes
Location of positive sites in cortical mapping
Time frame: During surgery
Incidence rate of intraoperative epilepsy induced by direct cortical stimulation
Time frame: During surgery
Extent of resection
Time frame: Within 72h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Background: PubMed 24970097Tate 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.
- Background: PubMed 18172171Sanai 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.
- Background: PubMed 26894457Chang 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.
- Background: PubMed 25848923Duffau 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.
- Background: PubMed 26351094Wu 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.
- Background: PubMed 25190682Wu 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.
- Background: PubMed 28334963Nakai 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.
- Background: PubMed 25978714Breshears 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.
- Background: PubMed 23850046Lu 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.
- Background: PubMed 29499015Ritaccio 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.
- Individual participant dataSharing planned: Undecided. Please refer to the principle investigator for participants' data.
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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.
Jinsong Wu, MD principal investigator
Huashan Hospital
Dongxiao Zhuang, MD study director
Huashan Hospital
Tianming Qiu, MD study director
Huashan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative direct cortical electrical stimulation and Intraoperative direct subcortical electrical stimulation in people with Glioma, run by Huashan Hospital at 3 sites in China.
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 11 inclusion and 9 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jinsong Wu, MD (86-021-52887200, wjsongc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of postoperative language deficits (time frame: The first month and the third month after surgery). 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 NCT03641391, which also lists 10 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 22 Aug 2018.