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Strategic Intervention on Preserving Motor Function During Awake Craniotomy

Primary Purpose

Glioma

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Awake craniotomy

About this trial

This is an interventional treatment trial for Glioma focused on measuring glioma, awake craniotomy, motor function, recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1)Age ≥ 18 years <65 years; 2)Histopathological diagnosis with low grade glioma (LGG) according to the 2021 World Health Organization (WHO) criteria; 3)Patients with primary type III (the tumor is less than 5 mm away from the posterior limb of the inner capsule) supratentorial glioma in the motor area confirmed by radiologist; 4)No history of biopsy, radiotherapy, or chemotherapy.

Exclusion Criteria:

1) Patients who received radiotherapy, chemotherapy or anti-tumor biotherapy within 1 month before the test; 2) Patients who received immunotherapy within 3 months before the test; 3) Patients who participated in other clinical trials within 3 months before the test ; 4) Patients with a history of severe allergies or allergies; 5) Pregnancy, breastfeeding or those who are fertile but have not taken contraceptive measures; 6) Have other serious medical diseases or severe uncontrollable infections; 7) Drugs and drugs Abuse, long-term alcoholism and AIDS patients; 8) Those who have uncontrollable seizures, or lose self-control due to mental illness.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New surgical plan group

Traditional surgical plan group

Arm Description

The investigators use monopolar stimulators to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule in type III motor area glioma patients.

The investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected.

Outcomes

Primary Outcome Measures

Motor function preserved better in new surgical plan group

Motor function of the participants in new surgical plan group is better preserved and recover faster than the participants in traditional surgical group.The difference between the motor functions of two groups are analyzed using t-test or chi-square test according to the type of data.

Secondary Outcome Measures

Full Information

NCT ID

NCT05143788

First Posted

November 23, 2021

Last Updated

December 6, 2021

Sponsor

Beijing Neurosurgical Institute

Collaborators

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05143788

Brief Title

Strategic Intervention on Preserving Motor Function During Awake Craniotomy

Official Title

Strategic Intervention on Preserving Motor Function With Application of Monopolar Stimulator During Awake Glioma Resection Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2021 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Neurosurgical Institute

Collaborators

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery.

Detailed Description

This study concentrates on patients with type III motor area glioma. In the awake surgery, The investigators compare the new surgical plan, which the investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule. For the traditional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. This study is designed to determine whether the new surgical plan is more suitable for type III motor area glioma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma

Keywords

glioma, awake craniotomy, motor function, recovery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

New surgical plan group

Arm Type

Experimental

Arm Description

The investigators use monopolar stimulators to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule in type III motor area glioma patients.

Arm Title

Traditional surgical plan group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Awake craniotomy

Intervention Description

The awake neurosurgical procedure performed on the brain is to provide a real-time neurological functions monitoring in order to preserve the functions of brain to the greatest extent.

Primary Outcome Measure Information:

Title

Motor function preserved better in new surgical plan group

Description

Time Frame

through study completion, an average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1)Age ≥ 18 years <65 years; 2)Histopathological diagnosis with low grade glioma (LGG) according to the 2021 World Health Organization (WHO) criteria; 3)Patients with primary type III (the tumor is less than 5 mm away from the posterior limb of the inner capsule) supratentorial glioma in the motor area confirmed by radiologist; 4)No history of biopsy, radiotherapy, or chemotherapy. Exclusion Criteria: 1) Patients who received radiotherapy, chemotherapy or anti-tumor biotherapy within 1 month before the test; 2) Patients who received immunotherapy within 3 months before the test; 3) Patients who participated in other clinical trials within 3 months before the test ; 4) Patients with a history of severe allergies or allergies; 5) Pregnancy, breastfeeding or those who are fertile but have not taken contraceptive measures; 6) Have other serious medical diseases or severe uncontrollable infections; 7) Drugs and drugs Abuse, long-term alcoholism and AIDS patients; 8) Those who have uncontrollable seizures, or lose self-control due to mental illness.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Jiang, MD and PhD

Phone

+86-010-67021832

taojiang1964@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuhao Guo, MD

Phone

+8613552339200

DanielGuoMD@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Jiang, MD and PhD

Organizational Affiliation

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The investigators do not plan to share individual participant data with other researchers

Citations:

PubMed Identifier

32350781

Citation

Fang S, Li Y, Wang Y, Zhang Z, Jiang T. Awake craniotomy for gliomas involving motor-related areas: classification and function recovery. J Neurooncol. 2020 Jun;148(2):317-325. doi: 10.1007/s11060-020-03520-w. Epub 2020 Apr 29.

Results Reference

result

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Strategic Intervention on Preserving Motor Function During Awake Craniotomy

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