N/A
N=58
Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
Glioma, Motor Pathway
Bottom Line
View on ClinicalTrials.gov: NCT01351337 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Extent of Tumor Resection — 40; 7; 7; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Huashan Hospital
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Tumor Resection |
40; 7; 7; 4 | — |
| SECONDARY Postoperative Motor Function and Long-time Functional Status |
41; 11; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01351337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.