| 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
|
|
|
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
|
|
|
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). |