Strategic Intervention on Preserving Language Function During Awake Craniotomy

Beijing Neurosurgical Institute

Status: Not yet enrolling

Conditions: Glioma

Treatments: Procedure: Awake craniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05143775

KY 2020-099-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

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 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.

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, those points would be retained to avoiding language function impairment after the tumor resection.

Treatment:

Procedure: Awake craniotomy