Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
4 april 2015 uppdaterad av: Jinsong Wu, Huashan Hospital
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Interventionell
Inskrivning (Faktisk)
58
Fas
- Inte tillämpbar
Kontakter och platser
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Studieorter
-
-
Shanghai
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Shanghai, Shanghai, Kina, 200000
- Hushan Hospital, Fudan University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 år till 75 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: intraoperative functional monitoring
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All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Extent of Tumor Resection
Tidsram: within 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.
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within 3 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Motor Function and Long-time Functional Status
Tidsram: 3 days to 6 months after surgery
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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.
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3 days to 6 months after surgery
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results
Tidsram: During the operation
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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.
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During the operation
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Sponsor
Samarbetspartners
Utredare
- Studiestol: Liangfu Zhou, Doctorate, Huashan Hospital
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2008
Primärt slutförande (Faktisk)
1 juni 2009
Avslutad studie (Faktisk)
1 februari 2013
Studieregistreringsdatum
Först inskickad
9 maj 2011
Först inskickad som uppfyllde QC-kriterierna
9 maj 2011
Första postat (Uppskatta)
10 maj 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 07QA14008 (Annat bidrag/finansieringsnummer: The govermment of Shanghai, China)
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