Strategic Intervention on Preserving Language Function During Awake Craniotomy

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05143775
• Other study ID #: KY 2020-099-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: June 2024

Study information

• Verified date: December 2021
• Source: Beijing Neurosurgical Institute
• Contact: Shimeng Weng, MD
• Phone: +8618610066686
• Email: wsmannie[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

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

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

References & Publications (1)

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;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
Primary	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.	From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.