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CTRI Number  CTRI/2024/02/063352 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Assessing the functional outcome of the spinal tumour surgery 
Scientific Title of Study   Evaluation of Neurophysiological markers as a prognostic measure for the neurosurgical excision of Intradural spinal tumours 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kaviraja Udupa MD PhD 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Neurophysiology National Institute of Mental Health and Neuro Sciences NIMHANS Hosur Road Bangalore INDIA

Bangalore
KARNATAKA
560029
India 
Phone  08026995914  
Fax    
Email  kaviudupa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MS PARANI L 
Designation  Ph.D. Research Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Neurophysiology National Institute of Mental Health and Neuro Sciences NIMHANS Hosur Road Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  7373354333  
Fax    
Email  paraniphysio2016@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MS PARANI L 
Designation  Ph.D. Research Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Neurophysiology National Institute of Mental Health and Neuro Sciences NIMHANS Hosur Road Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  7373354333  
Fax    
Email  paraniphysio2016@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, Hosur Road, Bengaluru-560029 (NIMHANS) 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neuro Sciences NIMHANS 
Address  Department of Neurophysiology, National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bengaluru, INDIA 560 029  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kaviraja Udupa MD PhD  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES  Department of Neurosurgery, National Institute of Mental Health and Neuro Sciences, (NIMHANS), Gate No:4 Hosur Road, Bengaluru, INDIA 560 029
Bangalore
KARNATAKA 
91-80-26995914

kaviudupa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D334||Benign neoplasm of spinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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) 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  Pre surgical Functional scale assessment-Intraoperative-Monitoring -Post operative comparing functional scale with immediate and 3-6 months of post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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).

 
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