GliomaNCT05143775
Strategic Intervention on Preserving Language Function During Awake Craniotomy
A study testing Awake craniotomy in people with Glioma, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study is designed to compare the language function after traditional or a new surgical plan during awake craniotomy for glioma resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma
- What is being tested?
- Awake craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2021to Jun 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1, patients with glioma near or on the language function area that have the necessity to undergo awake craniotomy and language function identification during tumor resection
Who cannot join
- patients with incompleted monitoring procedures;
- paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: Strategic Intervention on Preserving Language Function During Awake Craniotomy for Glioma Resection
This study is designed to compare the language function after traditional or a new surgical plan during awake craniotomy for glioma resection.
Read the detailed description
This study concentrates on patient who has type II language area glioma occupation. The investigators designed new surgical plan which is using monopolar stimulator to determine and retain the tumor margin within 5 mm from the posterior superior longitudinal fasciculus or posterior arcuate fasciculus. For the tradiitional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After they positive points are identified by stimulator, the positive points are retained to preserve the motor function while all the negative points of the tumor are resected. This study is to determine whether the new surgical plan is more suitable for type II language area glioma occupation.
- Conditions
- Glioma
- Being tested
- Awake craniotomy
- Keywords
- functional preservation, awake craniotomy, language impairment
- Medical subject headings
- Glioma, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake craniotomyProcedure or surgery
Randomly select 30 participants to implement new surgical plan, which is using a monopolar stimulator to determine positive function sites and save tumors within 5 mm of the posterior superior longitudinal fasciculus/arcuate fasciculus
| Study group | Role | What they receive |
|---|---|---|
| new surgical plan group | Experimental | The investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm in the sensitive area which is posterior superior longitudinal fasciculus or posterior arcuate fasciculus. Receives: Procedure: Awake craniotomy |
| traditional surgical plan group | Active comparator | The investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified, those points would be retained to avoiding language function impairment after the tumor resection. Receives: Procedure: Awake craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the language impairment rate
The ratio of language function recovery in patients with new surgical plan would higher than those receive traditional surgical plan. The main tool is to use Western Aphasia Battery (WAB) language evaluation form to record each patient's language ability in 4-7days after surgery and every other 3 months. The executive function and attention would also be evaluated by cognitive assessment (MoCA) and Mini-Mental State Exam (MMSE). Each patient's scores and reponse time would be used to compare the differences between two surgical plans.
Measured: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
Change of the survival rate
The new surgical plan preserves the language function to improve the quality of life, in order to influence the patient's length of life after surgery. Hence, the overall survival days of patients in two surgical plans would be compared by recording patients' date of death from any cause.
Measured: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Tao, Study chair, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143775
- Sponsor's protocol ID
- KY 2020-099-01
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators don't plan to share individual participant data with other researchers
Publications
Fang S, Liang Y, Li L, Wang L, Fan X, Wang Y, Jiang T. Tumor location-based classification of surgery-related language impairments in patients with glioma. J Neurooncol. 2021 Nov;155(2):143-152. doi: 10.1007/s11060-021-03858-9. Epub 2021 Oct 1.
PubMed 34599481Li Y, Weng S, Dong J, Wang J, Zhang Z, Fan X, Wang Y, Ma W, Jiang T, Fang S. Awake Craniotomy for Eloquent Region Glioblastoma Classified by Tumor Location-A Retrospective and Prospective Cohort Study. CNS Neurosci Ther. 2026 Sep;32(9):e71126. doi: 10.1002/cns.71126.
PubMed 42687123
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Intervention on Preserving Language Function During Awake Craniotomy for Glioma Resection
- ClinicalTrials.gov ID
- NCT05143775
- Acronym / sponsor ID
- KY 2020-099-01
- Conditions
- Glioma
- Keywords
- functional preservation, awake craniotomy, language impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Dec 2021 (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.
This study is designed to compare the language function after traditional or a new surgical plan during awake craniotomy for glioma resection.
Detailed description
This study concentrates on patient who has type II language area glioma occupation. The investigators designed new surgical plan which is using monopolar stimulator to determine and retain the tumor margin within 5 mm from the posterior superior longitudinal fasciculus or posterior arcuate fasciculus. For the tradiitional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After they positive points are identified by stimulator, the positive points are retained to preserve the motor function while all the negative points of the tumor are resected. This study is to determine whether the new surgical plan is more suitable for type II language area glioma occupation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new surgical plan group | Experimental | Procedure: Awake craniotomyThe investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm in the sensitive area which is posterior superior longitudinal fasciculus or posterior arcuate fasciculus. |
| traditional surgical plan group | Active comparator | Procedure: Awake craniotomyThe investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified, those points would be retained to avoiding language function impairment after the tumor resection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1, patients with glioma near or on the language function area that have the necessity to undergo awake craniotomy and language function identification during tumor resection
Key exclusion criteria (2 listed)
- patients with incompleted monitoring procedures;
- paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.
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 |
|---|---|---|
| Awake craniotomyRandomly select 30 participants to implement new surgical plan, which is using a monopolar stimulator to determine positive function sites and save tumors within 5 mm of the posterior superior longitudinal fasciculus/arcuate fasciculus | Procedure or surgery | new surgical plan group, traditional surgical plan group |
Primary outcome
Change of the language impairment rate
Time frame: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
The ratio of language function recovery in patients with new surgical plan would higher than those receive traditional surgical plan. The main tool is to use Western Aphasia Battery (WAB) language evaluation form to record each patient's language ability in 4-7days after surgery and every other 3 months. The executive function and attention would also be evaluated by cognitive assessment (MoCA) and Mini-Mental State Exam (MMSE). Each patient's scores and reponse time would be used to compare the differences between two surgical plans.
Change of the survival rate
Time frame: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
The new surgical plan preserves the language function to improve the quality of life, in order to influence the patient's length of life after surgery. Hence, the overall survival days of patients in two surgical plans would be compared by recording patients' date of death from any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Background: PubMed 34599481Fang S, Liang Y, Li L, Wang L, Fan X, Wang Y, Jiang T. Tumor location-based classification of surgery-related language impairments in patients with glioma. J Neurooncol. 2021 Nov;155(2):143-152. doi: 10.1007/s11060-021-03858-9. Epub 2021 Oct 1.
- Derived from this study: PubMed 42687123Li Y, Weng S, Dong J, Wang J, Zhang Z, Fan X, Wang Y, Ma W, Jiang T, Fang S. Awake Craniotomy for Eloquent Region Glioblastoma Classified by Tumor Location-A Retrospective and Prospective Cohort Study. CNS Neurosci Ther. 2026 Sep;32(9):e71126. doi: 10.1002/cns.71126.
- Individual participant dataSharing planned: No. The investigators don't plan to share individual participant data with other researchers
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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.
Jiang Tao study chair
Beijing Neurosurgical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake craniotomy in people with Glioma, run by Beijing Neurosurgical Institute at 1 site 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 1 inclusion and 2 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shimeng Weng, MD (+8618610066686, wsmannie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the language impairment rate (time frame: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.). The study lists 2 primary outcomes in all. 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 NCT05143775, which also lists 2 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 3 Jan 2022.