| CTRI Number |
CTRI/2024/07/070187 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of functional outcome of brain tumor surgery |
|
Scientific Title of Study
|
Neurophysiology and Imaging Measures in Predicting Motor Outcome of Motor Eloquent Glioma Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathyaprabha TN |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neurophysiology
NIMHANS
Hosur Road
Bengaluru Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995172 |
| Fax |
|
| Email |
drsathyaprabha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shanmugasundaram K |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neurophysiology
NIMHANS
Hosur Road
Bengaluru Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9488103776 |
| Fax |
|
| Email |
shasun99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shanmugasundaram K |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neurophysiology
NIMHANS
Hosur Road
Bengaluru Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9488103776 |
| Fax |
|
| Email |
shasun99@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences NIMHANS
Hosur Road
Bangalore
Karnataka
India 560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
National Institute of Mental Health and Neurosciences
Hosur Road
Bangalore
Karnataka |
| 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 Sathyaprabha TN |
National Institute of Mental Health and Neurosciences |
Room No 1010 CNN laboratory
Special OPD block
Department of Neurophysiology
NIMHANS Bangalore
Karnataka
India 560029
Bangalore
KARNATAKA |
08026995172
drsathyaprabha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee (Basic and Neurosciences Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
There is no interventions provided, only data will be collected from the patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically confirmed cases of gliomas involving motor eloquent and perirolandic regions
Patient willing to participate in the study and give informed written consent |
|
| ExclusionCriteria |
| Details |
Patients with MRC motor power scale less than 2 will be excluded
Patients with advanced symptoms of neurological cardio and respirator complications
Patients with other neurological conditions such muscular dystrophies Parkinsonism Alzheimers and other metabolic disorders
Patients with evidence of any other malignancy
Patients with contraindications to TMS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predicting motor outcome of brain tumor glioma surgery using different neurophysiological parameters(TMS and IONM) |
baseline (Preoperative)
During Surgery (Intraoperative)
1-2 weeks after surgery (Postoperative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predicting motor outcome of brain tumor glioma surgery using different neurophysiological parameters(HRV, EEG & DTI) |
baseline (Preoperative)
During Surgery (Intraoperative)
1-2 weeks after surgery (Postoperative) |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/08/2024 |
| 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
|
The brain tumor is an abnormal growth of cells within the brain or central nervous systemThese tumors can be benign (noncancerous) or malignant (cancerous) To evaluate the utility of various neurophysiological parameters including IONM, TMS and neural connectivity (functional connectivity- EEG, structural connectivity- DTI/MRI) as an effective predictive measure of motor outcome in glioma surgery involving the motor eloquent region. |