Strategic Intervention on Preserving Language Function During Awake Craniotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2024-06-30

Brief Summary

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This study is designed to compare the language function after traditional or a new surgical plan during awake craniotomy for glioma resection.

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Detailed Description

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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.

Conditions

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Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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new surgical plan group

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.

Group Type EXPERIMENTAL

Awake craniotomy

Intervention Type PROCEDURE

Randomly select 30 participants to implement new surgical plan, which is using a monopolar stimulator to determine positive function sites and save tumors within 5 mm of the posterior superior longitudinal fasciculus/arcuate fasciculus

traditional surgical plan group

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.

Group Type ACTIVE_COMPARATOR

Awake craniotomy

Intervention Type PROCEDURE

Randomly select 30 participants to implement new surgical plan, which is using a monopolar stimulator to determine positive function sites and save tumors within 5 mm of the posterior superior longitudinal fasciculus/arcuate fasciculus

Interventions

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Awake craniotomy

Randomly select 30 participants to implement new surgical plan, which is using a monopolar stimulator to determine positive function sites and save tumors within 5 mm of the posterior superior longitudinal fasciculus/arcuate fasciculus

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No