Strategic Intervention on Preserving Language Function During Awake Craniotomy

NCT05143775 | Unknown DMC

• 1 other identifier: KY 2020-099-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioma

Keywords

functional preservation; awake craniotomy; language impairment

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

new surgical plan group

EXPERIMENTAL

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

traditional surgical plan group

ACTIVE COMPARATOR

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

Interventions

Awake craniotomy PROCEDURE

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

new surgical plan group; traditional surgical plan group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• , 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

You may not qualify if:

• patients with incompleted monitoring procedures;
• paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

Location

Related 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.

  PMID: 34599481 BACKGROUND

MeSH Terms

Conditions

Glioma; Language Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiang Tao

  Beijing Neurosurgical Institute

  STUDY CHAIR

Central Study Contacts

Shimeng Weng, MD

CONTACT

+8618610066686; wsmannie@gmail.com

Shengyu Fang, MD

CONTACT

+8613466331405; fangtuo1@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 3, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)