An interventional study of Functional navigation in Tumor, Brain, Arteriovenous Malformations and Cavernoma, sponsored by Sklifosovsky Institute of Emergency Care. Suspended at 1 site in Russian Federation. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Sklifosovsky Institute of Emergency Care · Not applicable, Interventional, and Treatment
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery.
Functional images (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), tractography) loaded in neuronavigation are called functional navigation. It is usually combined with anatomical data and allows to display eloquent brain areas. Currently there are plenty of studies concerning possibilities of it's use. In our research we plan to confirm this data and to supplement them with calculating a safe distance from motor areas to various mass lesions in preoperative scans where neurological deficits is not likely to appear after surgery. In case of success this data can be a foundation for further researches specifying indications for use of intraoperative neuromonitoring and possibility of it's replacement with functional navigation in some cases.
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. For each patient a surgeon intraoperatively will assess locations of motor cortex and corticospinal tract found with direct cortical and subcortical stimulation and capture them. After surgery he will compare this data with functional preoperative scans and virtual motor centers constructed based on tractography. Influence of various factors on precision of functional navigation will be studied and safe distance between motor brain areas and mass lesion borders will be calculated.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Sklifosovsky Institute of Emergency Care is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Image-guided resection of brain tumors and vascular malformations
Device: Functional navigation
Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring
Accuracy of functional navigation (in millimeters)
Maximal distance from the most remote margin of cortical hand/leg motor area or corticospinal tract in the area of corona radiata in functional navigation to the nearest margin of this area/tract in direct cortical/subcortical stimulation
Time frame: Intraoperatively
Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
Maximal distance from the most remote margin of cortical hand/leg motor area, built according to tractography and loaded into navigation, to the nearest margin of this area in direct cortical stimulation
Time frame: Intraoperatively
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
Maximal distance from the most remote margin of cortical hand/leg motor area in fMRI/TMS to the nearest margin of precentral gyrus
Time frame: Within 2 days before surgery
Factors, violating precision of fMRI/TMS/tractography
Which factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography
Time frame: Within 2 days before surgery
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Time frame: Within 10 days after surgery
Distance to stop resection border (in millimeters)
Minimal distance from the nearest margin of cortical hand/leg motor area or corticospinal tract to the nearest border of resection of tumor/vascular malformation
Time frame: Intraoperatively
Safe resection distance in functional navigation (in millimeters)
This outcome is only measured in patients with no deterioration of motor function after surgery. Safe resection distance = accuracy of functional navigation + distance to stop resection border
Time frame: Within 10 days after surgery
Duration of direct cortical and subcortical mapping (in minutes)
How long did it take to perform direct cortical and subcortical mapping
Time frame: Intraoperatively
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time frame: Within 48 hours after surgery
Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Time frame: Within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Plan to share: No
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Sklifosovsky Institute of Emergency Care