Strategic Intervention on Preserving Motor Function During Awake Craniotomy

NCT05143788 | Unknown DMC

• 1 other identifier: JYY-2019-5
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Glioma

Keywords

glioma; awake craniotomy; motor function; recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 2 years

Study Arms (2)

New surgical plan group

EXPERIMENTAL

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.

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 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.

Procedure: Awake craniotomy

Interventions

Awake craniotomy PROCEDURE

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.

New surgical plan group; Traditional surgical plan group

Eligibility Criteria

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

You may qualify if:

• )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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead
• Beijing Tiantan Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 32350781 RESULT

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tao Jiang, MD and PhD

  Beijing Neurosurgical Institute and Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Tao Jiang, MD and PhD

CONTACT

+86-010-67021832; taojiang1964@163.com

Yuhao Guo, MD

CONTACT

+8613552339200; DanielGuoMD@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• 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: December 1, 2023
• Last Updated: December 20, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share