Clinical trial NCT05143788: Strategic Intervention on Preserving Motor Function During Awake Craniotomy
Official title: Strategic Intervention on Preserving Motor Function With Application of Monopolar Stimulator During Awake Glioma Resection Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: glioma
awake craniotomy
motor function
recovery
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Motor function preserved better in new surgical plan group
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
name: Tao Jiang, MD and PhD
role: STUDY_DIRECTOR
References:
citation: 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.