Strategic Intervention on Preserving Language Function During Awake Craniotomy

Not Applicable

• Conditions: Glioma
• Interventions: Procedure: Awake craniotomy

• Registration Number: NCT05143775
• Lead Sponsor: Beijing Neurosurgical Institute

Brief Summary

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 Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Status Verified: 2021-12
• Study Start: 2021-12
• Study First Posted: 2021-12-03
• Last Update Submitted: 2021-12-26
• Last Update Posted: 2022-01-03
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

1. patients with incompleted monitoring procedures;
2. paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional surgical plan group	Awake craniotomy	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.
new surgical plan group	Awake craniotomy	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.

Primary Outcome Measures

Name	Time	Method
Change of the language impairment rate	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	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.

Trial Locations

Locations (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China