Strategic Intervention on Preserving Language Function During Awake Craniotomy

December 26, 2021 updated by: Beijing Neurosurgical Institute

Strategic Intervention on Preserving Language Function During Awake Craniotomy for Glioma Resection

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: 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
ACTIVE_COMPARATOR: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the language impairment rate
Time Frame: 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.
From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
Change of the survival rate
Time Frame: 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.
From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (ACTUAL)

December 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 26, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY 2020-099-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators don't plan to share individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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