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

This study has been completed.
Sponsor:
Collaborator:
Shanghai Municipal Science and Technology Commission
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01351337
First received: May 9, 2011
Last updated: April 4, 2015
Last verified: April 2015

May 9, 2011
April 4, 2015
October 2008
June 2009   (final data collection date for primary outcome measure)
Extent of Tumor Resection [ Time Frame: within 3 days ] [ Designated as safety issue: No ]
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.
Extent of tumor resection and the integrity of the PTs confirmed by postoperative MRI [ Time Frame: within 3 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01351337 on ClinicalTrials.gov Archive Site
Postoperative Motor Function and Long-time Functional Status [ Time Frame: 3 days to 6 months after surgery ] [ Designated as safety issue: No ]
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.
postoperative motor function and long-time functional status assessed clinically [ Time Frame: more than 6 months ] [ Designated as safety issue: No ]
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results [ Time Frame: During the operation ] [ Designated as safety issue: Yes ]
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.
Not Provided
 
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.

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)

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Glioma, Motor Pathway
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
intraoperative functional monitoring
intraoperative functional monitoring
Intervention: Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
February 2013
June 2009   (final data collection date for primary outcome measure)

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.
Both
6 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01351337
07QA14008, 07QA14008
Yes
Jinsong Wu, Huashan Hospital
Huashan Hospital
Shanghai Municipal Science and Technology Commission
Study Chair: Liangfu Zhou, Doctorate Huashan Hospital, Fudan University
Huashan Hospital
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP