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

Not Applicable
Completed
Conditions
Glioma, Motor Pathway
Interventions
Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
Registration Number
NCT01351337
Lead Sponsor
Huashan Hospital
Brief Summary

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.

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)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
intraoperative functional monitoringdiffusion tensor tractography neuronavigation and intraoperative subcortical stimulationintraoperative functional monitoring
Primary Outcome Measures
NameTimeMethod
Extent of Tumor Resectionwithin 3 days

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.

Secondary Outcome Measures
NameTimeMethod
Postoperative Motor Function and Long-time Functional Status3 days to 6 months after surgery

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.

Trial Locations

Locations (1)

Hushan Hospital, Fudan University

🇨🇳

Shanghai, Shanghai, China

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