Strategic Intervention on Preserving Motor Function During Awake Craniotomy

Glioma Clinical Trial

Official title:

Strategic Intervention on Preserving Motor Function With Application of Monopolar Stimulator During Awake Glioma Resection Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05143788
• Other study ID #: JYY-2019-5
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2021
• Source: Beijing Neurosurgical Institute
• Contact: Tao Jiang, MD and PhD
• Phone: +86-010-67021832
• Email: taojiang1964[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Procedure:
• Awake craniotomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute	Beijing Tiantan Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 years