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Strategic Intervention on Preserving Language Function During Awake Craniotomy

Primary Purpose

Glioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Awake craniotomy
Sponsored by
Beijing Neurosurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glioma focused on measuring functional preservation, awake craniotomy, language impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

new surgical plan group

traditional surgical plan group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change of the language impairment rate
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2021
Last Updated
December 26, 2021
Sponsor
Beijing Neurosurgical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05143775
Brief Title
Strategic Intervention on Preserving Language Function During Awake Craniotomy
Official Title
Strategic Intervention on Preserving Language Function During Awake Craniotomy for Glioma Resection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Neurosurgical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
functional preservation, awake craniotomy, language impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
new surgical plan group
Arm Type
Experimental
Arm 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.
Arm Title
traditional surgical plan group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Awake craniotomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of the language impairment rate
Description
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.
Time Frame
From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
Title
Change of the survival rate
Description
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.
Time Frame
From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: patients with incompleted monitoring procedures; paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimeng Weng, MD
Phone
+8618610066686
Email
wsmannie@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shengyu Fang, MD
Phone
+8613466331405
Email
fangtuo1@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Tao
Organizational Affiliation
Beijing Neurosurgical Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators don't plan to share individual participant data with other researchers
Citations:
PubMed Identifier
34599481
Citation
Fang S, Liang Y, Li L, Wang L, Fan X, Wang Y, Jiang T. Tumor location-based classification of surgery-related language impairments in patients with glioma. J Neurooncol. 2021 Nov;155(2):143-152. doi: 10.1007/s11060-021-03858-9. Epub 2021 Oct 1. Erratum In: J Neurooncol. 2021 Oct 12;:
Results Reference
background

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Strategic Intervention on Preserving Language Function During Awake Craniotomy

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