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Strategic Intervention on Preserving Language Function During Awake Craniotomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05143775
Enrollment
60
Registered
2021-12-03
Start date
2021-12-31
Completion date
2024-06-30
Last updated
2022-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Keywords

functional preservation, awake craniotomy, language impairment

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.

Interventions

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

Sponsors

Beijing Neurosurgical Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of the language impairment rateFrom 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.
Change of the survival rateFrom 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.

Countries

China

Contacts

Primary ContactShimeng Weng, MD
wsmannie@gmail.com+8618610066686
Backup ContactShengyu Fang, MD
fangtuo1@aliyun.com+8613466331405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026