Evaluation of Neurophysiological markers as a prognostic measure for the neurosurgical excision of Intradural spinal tumours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- This study is an attempt to evaluate the efficacy of neurophysiological markers including intraoperative neurophysiological monitoring to evaluate the efficacy of neurosurgical excision of Intradural spinal tumors
研究概览
简要总结
A spinal tumor is an abnormal mass of tissue within or surrounding the spinal cord and or spinal column. There are two main types of spinal tumors classified based on their location extradural and intradural. Extradural tumors are located outside the dura mater lining and are most commonly metastatic. Intradural extramedullary (80% of intraspinal tumors in adults, 65–70% of intraspinal tumors in children Intradural tumors are located inside the dura mater lining and again subdivided into Intradural Intramedullary (ID-IMST) and Intradural extramedullary (ID-EMST) tumors. Surgical resection of this tumor carries the risk of new neurological deficits in the postoperative period. Intraoperative neurophysiological monitoring (IONM) and mapping represent an effective method of identifying and monitoring in real-time the functional integrity of both the spinal cord (SC) and the nerve roots (NRs) emerging out of SC. Despite agreement on favoring the use of IONM in IDSCT surgery, in this era of evidence-based medicine, there is still a need to demonstrate the effective role of IONM and other neurophysiological markers in IDSCT surgery in achieving oncosurgical benefits and optimizing patient safety In the present proposed study, we focused on the rationale for and the accuracy (sensitivity, specificity, and positive and negative predictive values) of IONM and other pre-surgical biomarkers in IMSCT neurosurgery with specific emphasis on the role of IONM in reducing the incidence of postoperative neurological deficits. We hypothesize that Multimodal IONM aids in achieving maximum safe resection of spinal lesions and prognostic marker for optimal postoperative functional outcome and represents an important tool for preserving neuronal structures and achieving optimal postoperative functional outcomes, and also, we would be exploring the Neurophysiological measures such as HRV, AFT, ECHO and PFT measures could predict the outcome of the patients with Intradural spinal tumor.
The assessments would be carried out at five-time intervals, pre-surgical evaluation, during surgery, immediately after Surgery (within 24 Hrs.) first week of post-operative, and follow-up(3-6moth).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •Clinically confirmed cases of Intradural spinal tumor.
- •Age between 20 to 50 years & Both Gender is included and Patients in the ambulatory phase (Modified McCormick Scale Grade I-III) & Nurick score classification (Grade 0-II).
排除标准
- •Patients in non-ambulatory phase (Modified McCormick Scale Grade IV-V) & Nurick score classification (Grade III-V).
- •Patients with advanced symptoms of neurological, cardio and respiratory complications.
- •Patients with other neurological conditions such muscular dystrophies, Parkinsonism, Alzheimer’s and other metabolic disorders.
- •Patients with evidence of any other malignancy.
结局指标
主要结局
This study is an attempt to evaluate the efficacy of neurophysiological markers including intraoperative neurophysiological monitoring to evaluate the efficacy of neurosurgical excision of Intradural spinal tumors
时间窗: Pre surgical Functional scale assessment-Intraoperative-Monitoring -Post operative comparing functional scale with immediate and 3-6 months of post operative period
次要结局
- This study is an attempt to evaluate the efficacy of neurophysiological markers including intraoperative neurophysiological monitoring to evaluate the efficacy of neurosurgical excision of Intradural spinal tumors by Utilizing HRV AFT ECHO PFT measures to evaluate the functional outcomes of neurosurgical excision of Intradural spinal tumors(Pre operative assessment of HRV AFT ECHO PFT then comparing with Post operative immediate within 7 days then 3 to 6 months)
研究者
Dr Kaviraja Udupa MD PhD
National Institute of Mental Health and Neuro Sciences (NIMHANS)
