GliomaNCT05143788
Strategic Intervention on Preserving Motor Function During Awake Craniotomy
A study testing Awake craniotomy in people with Glioma, run by Beijing Neurosurgical Institute.
Trial summary
This study aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioma
- What is being tested?
- Awake craniotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)Age ≥ 18 years <65 years; 2)Histopathological diagnosis with low grade glioma (LGG) according to the 2021 World Health Organization (WHO) criteria; 3)Patients with primary type III (the tumor is less than 5 mm away from the posterior limb of the inner capsule) supratentorial glioma in the motor area confirmed by radiologist; 4)No history of biopsy, radiotherapy, or chemotherapy.
Who cannot join
- 1) Patients who received radiotherapy, chemotherapy or anti-tumor biotherapy within 1 month before the test; 2) Patients who received immunotherapy within 3 months before the test; 3) Patients who participated in other clinical trials within 3 months before the test ; 4) Patients with a history of severe allergies or allergies; 5) Pregnancy, breastfeeding or those who are fertile but have not taken contraceptive measures; 6) Have other serious medical diseases or severe uncontrollable infections; 7) Drugs and drugs Abuse, long-term alcoholism and AIDS patients; 8) Those who have uncontrollable seizures, or lose self-control due to mental illness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Strategic Intervention on Preserving Motor Function With Application of Monopolar Stimulator During Awake Glioma Resection Surgery
This study aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery.
Read the detailed description
This study concentrates on patients with type III motor area glioma. In the awake surgery, The investigators compare the new surgical plan, which the investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule. For the traditional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. This study is designed to determine whether the new surgical plan is more suitable for type III motor area glioma patients.
- Conditions
- Glioma
- Being tested
- Awake craniotomy
- Keywords
- glioma, awake craniotomy, motor function, recovery
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake craniotomyProcedure or surgery
The awake neurosurgical procedure performed on the brain is to provide a real-time neurological functions monitoring in order to preserve the functions of brain to the greatest extent.
| Study group | Role | What they receive |
|---|---|---|
| New surgical plan group | Experimental | The investigators use monopolar stimulators to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule in type III motor area glioma patients. 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 by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. Receives: Procedure: Awake craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function preserved better in new surgical plan group
Motor function of the participants in new surgical plan group is better preserved and recover faster than the participants in traditional surgical group.The difference between the motor functions of two groups are analyzed using t-test or chi-square test according to the type of data.
Measured: through study completion, an average of 2 years
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 completionDec 2023 (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
- Treatment
- 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
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Tao Jiang, MD and PhD, Study director, Beijing Neurosurgical Institute and Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143788
- Sponsor's protocol ID
- JYY-2019-5
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data with other researchers
Publications
Fang S, Li Y, Wang Y, Zhang Z, Jiang T. Awake craniotomy for gliomas involving motor-related areas: classification and function recovery. J Neurooncol. 2020 Jun;148(2):317-325. doi: 10.1007/s11060-020-03520-w. Epub 2020 Apr 29.
PubMed 32350781Li 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 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Intervention on Preserving Motor Function With Application of Monopolar Stimulator During Awake Glioma Resection Surgery
- ClinicalTrials.gov ID
- NCT05143788
- Acronym / sponsor ID
- JYY-2019-5
- Conditions
- Glioma
- Keywords
- glioma, awake craniotomy, motor function, recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (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 aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery.
Detailed description
This study concentrates on patients with type III motor area glioma. In the awake surgery, The investigators compare the new surgical plan, which the investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule. For the traditional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. This study is designed to determine whether the new surgical plan is more suitable for type III motor area glioma patients.
Study design
- Primary purpose
- Treatment
- 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 monopolar stimulators to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule in type III motor area glioma patients. |
| 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 by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1)Age ≥ 18 years <65 years; 2)Histopathological diagnosis with low grade glioma (LGG) according to the 2021 World Health Organization (WHO) criteria; 3)Patients with primary type III (the tumor is less than 5 mm away from the posterior limb of the inner capsule) supratentorial glioma in the motor area confirmed by radiologist; 4)No history of biopsy, radiotherapy, or chemotherapy.
Key exclusion criteria (1 listed)
- 1) Patients who received radiotherapy, chemotherapy or anti-tumor biotherapy within 1 month before the test; 2) Patients who received immunotherapy within 3 months before the test; 3) Patients who participated in other clinical trials within 3 months before the test ; 4) Patients with a history of severe allergies or allergies; 5) Pregnancy, breastfeeding or those who are fertile but have not taken contraceptive measures; 6) Have other serious medical diseases or severe uncontrollable infections; 7) Drugs and drugs Abuse, long-term alcoholism and AIDS patients; 8) Those who have uncontrollable seizures, or lose self-control due to mental illness.
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 craniotomyThe awake neurosurgical procedure performed on the brain is to provide a real-time neurological functions monitoring in order to preserve the functions of brain to the greatest extent. | Procedure or surgery | New surgical plan group, Traditional surgical plan group |
Primary outcome
Motor function preserved better in new surgical plan group
Time frame: through study completion, an average of 2 years
Motor function of the participants in new surgical plan group is better preserved and recover faster than the participants in traditional surgical group.The difference between the motor functions of two groups are analyzed using t-test or chi-square test according to the type of data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Results publication: PubMed 32350781Fang S, Li Y, Wang Y, Zhang Z, Jiang T. Awake craniotomy for gliomas involving motor-related areas: classification and function recovery. J Neurooncol. 2020 Jun;148(2):317-325. doi: 10.1007/s11060-020-03520-w. Epub 2020 Apr 29.
- 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 do not 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.
Tao Jiang, MD and PhD study director
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Awake craniotomy in people with Glioma, run by Beijing Neurosurgical Institute.
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 1 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 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Tao Jiang, MD and PhD (+86-010-67021832, taojiang1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function preserved better in new surgical plan group (time frame: through study completion, an average of 2 years). 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 NCT05143788, 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 20 Dec 2021.