Strategic Intervention on Preserving Motor Function During Awake Craniotomy

Beijing Neurosurgical Institute

Status: Unknown

Conditions: Glioma

Treatments: Procedure: Awake craniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05143788

JYY-2019-5

Details and patient eligibility

About

This study aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

New surgical plan group

Experimental group

Description:

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.

Treatment:

Procedure: Awake craniotomy

Traditional surgical plan group

Active Comparator group

Description:

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.

Treatment:

Procedure: Awake craniotomy