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
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Glioma, Motor Pathway
Intervention: Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intraoperative Functional Monitoring

intraoperative functional monitoring and diffusion tensor tractography

All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation


Participant Flow:   Overall Study
    Intraoperative Functional Monitoring  
STARTED     58  
COMPLETED     58  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Age (range), y 44 (10-72) Female/male, n/n 21/37

Reporting Groups
  Description
Intraoperative Functional Monitoring

intraoperative functional monitoring

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


Baseline Measures
    Intraoperative Functional Monitoring  
Number of Participants  
[units: participants]
  58  
Age  
[units: years]
Mean (Full Range)
 
Patients enrolled     44  
   (10 to 72)  
Gender  
[units: participants]
 
Female     21  
Male     37  
Study Specific Measure [Tumor Location]  
[units: participants]
 
Frontal lobe     22  
Parietal lobe     13  
Insular lobe     12  
Temporal lobe     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Extent of Tumor Resection   [ Time Frame: within 3 days ]

2.  Secondary:   Postoperative Motor Function and Long-time Functional Status   [ Time Frame: 3 days to 6 months after surgery ]

3.  Other Pre-specified:   The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results   [ Time Frame: During the operation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The imaged motor pathway was reconstructed based on pre-opimages. An additional study that integrates real-time DTI tractography with high-field intraoperative MRI and DsCS for eloquent cerebral glioma surgery is currently underway in our department.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Jinsong Wu
Organization: Huashan Hospital
phone: 862152888771
e-mail: wjsongc@126.com


Publications of Results:

Responsible Party: Jinsong Wu, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01351337     History of Changes
Other Study ID Numbers: 07QA14008, 07QA14008
Study First Received: May 9, 2011
Results First Received: February 24, 2014
Last Updated: April 4, 2015
Health Authority: China: Food and Drug Administration