Strategic Intervention on Preserving Language Function During Awake Craniotomy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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:

1. patients with incompleted monitoring procedures; 2. paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05143775
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Neurosurgical Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jiang Tao
Principal Investigator Affiliation	Beijing Neurosurgical Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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

Contact a Trial Team

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International Sites

Beijing, Beijing, China

Status

Address

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing, 100005

Site Contact

wsmannie@gmail.com

+8618610066686

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