Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area

Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery

Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation. We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.

Study Overview

• Status: Completed
• Conditions: Glioma, Motor Pathway
• Intervention / Treatment: Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation

Detailed Description

Adverse effects caused by electrical stimulation during the operation were recorded. All subjects adopted early postoperative MRI examinations (within 3 days) to evaluate both the extent of tumor resection and the integrity of the PTs. Muscle strength was assessed preoperatively and postoperatively.The Karnofsky Performance Scale (KPS) was adopted for grading functional status at the 6-month evaluation. Further tumor progression interval and survival analysis was conducted for each subject with high-grade glioma (HGG)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Hushan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with an initial imaging diagnosis of single, unilateral, supratentorial primary glioma (or intrinsic neoplasm).
• The lesions were involved in PTs, comprising cortical regions in the motor or somatosensory areas, cortical regions adjacent to the central gyrus, subcortical regions with an infiltrative progression along the PTs, and temporal or insular regions in relation to the internal capsule.
• MRI enabled preoperative identification of patients in whom maximal tumor resection was likely to be achieved, and close PT approach within resection cavity at the time of surgery was possible.

Exclusion Criteria:

• patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with contraindications for MRI or direct electrical stimulation, and patients in whom initial muscle strength grades of the affected extremities was 2/5 or lower.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: intraoperative functional monitoring	Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation; All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Tumor Resection	Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas. The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume. Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.	within 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Motor Function and Long-time Functional Status	Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.	3 days to 6 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results	The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.	During the operation

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Shanghai Municipal Science and Technology Commission
• Investigators: Study Chair: Liangfu Zhou, Doctorate, Huashan Hospital

Publications and helpful links

General Publications

• Zhu FP, Wu JS, Song YY, Yao CJ, Zhuang DX, Xu G, Tang WJ, Qin ZY, Mao Y, Zhou LF. Clinical application of motor pathway mapping using diffusion tensor imaging tractography and intraoperative direct subcortical stimulation in cerebral glioma surgery: a prospective cohort study. Neurosurgery. 2012 Dec;71(6):1170-83; discussion 1183-4. doi: 10.1227/NEU.0b013e318271bc61.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 20, 2015
• Last Update Submitted That Met QC Criteria: April 4, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical; stimulation, Tractography
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 07QA14008 (Other Grant/Funding Number: The govermment of Shanghai, China)