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CTRI Number  CTRI/2024/09/074491 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Changes in regional brain oxygen levels blood flow velocity in brain and lung function tests in patients undergoing deep brain stimulation surgery A prospective observational study 
Scientific Title of Study   Perioperative changes in regional cerebral oxygenation cerebral blood flow velocity and pulmonary function tests in patients undergoing deep brain stimulation A Prospective Observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NITESH KUMAR 
Designation  SENIOR RESIDENT 
Affiliation  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES(NIMHANS) BENGALURU 
Address  Department of Neuroanaesthesia & Neurocritical care,3rd Floor, Faculty building, NIMHANS,Bengaluru Karnataka 560029 INDIA

Bangalore
KARNATAKA
560029
India 
Phone  9657436468  
Fax    
Email  nitesh5625@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MADHUSUDAN REDDY 
Designation  PROFESSOR 
Affiliation  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES (NIMHANS) BENGALURU 
Address  Department of Neuroanaesthesia & Neurocritical care,3rd Floor, Faculty building, NIMHANS,Bengaluru Karnataka 560029 INDIA

Bangalore
KARNATAKA
560029
India 
Phone  9880103088  
Fax    
Email  krmsr2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  MADHUSUDAN REDDY 
Designation  PROFESSOR 
Affiliation  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES (NIMHANS) BENGALURU 
Address  Department of Neuroanaesthesia & Neurocritical care,3rd Floor, Faculty building, NIMHANS,Bengaluru Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  9880103088  
Fax    
Email  krmsr2000@yahoo.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, BENGALURU, KARNATAKA PIN:560029 INDIA 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES NIMHANS BENGALURU 
Address  DEPARTMENT OF NEUROANAESTHESIA AND NEUROCRITICAL CARE, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, BENGALURU, KARNATAKA PIN 560029 INDIA 
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 NITESH KUMAR  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES  MAIN OPERATION THEATER,DEPARTMENT OF NEUROANAESTHESIA,OT-3,2ND FLOOR, NEUROCENTER BLOCK, NIMHANS, BENGALURU 560029
Bangalore
KARNATAKA 
9657436468

nitesh5625@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. All patients between 18-70 years of age undergoing DBS surgery.
2. ASA PS 1-3
 
 
ExclusionCriteria 
Details  1. Known respiratory pathology
2. ICSOL or head injury in the past
3. Known cardiac failure
4. Refusal of consent

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• The comparison of rSO2 (regionalcerebral oxygenation) changes during the DBS electrode placement, stimulation and after activation.  • rSO2 (regional cerebral oxygenation) values at baseline, intraoperatively during the DBS electrode placement & stimulation, 24 hours before and 24 hours after activation of battery 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the changes in middle cerebral artery velocity before electrode insertion & after insertion & activation of the electrode.
• To compare the change in rSO2 to the change in the MDS-UPDRS scale after DBS.
• To compare the change in pulmonary function test before electrode insertion, after insertion & activation of electrode.
 
Baseline, 24 hours before & 24 hours after activation of battery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/10/2024 
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="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Deep brain stimulation (DBS) is the functional surgery performed for Parkinson’s disease, dystonia, essential tremors, epilepsy, chronic pain, and psychiatric diseases (obsessive-compulsive disorder, refractory major depression). DBS is nondestructive, reversible, and adjustable surgical therapy performed based on the disease characteristic, treatment availability, and patient preferences .  DBS electrodes are placed bilaterally for Parkinson’s disease and unilaterally for essential tremors. DBS is known to improve the quality of life and reduce drug requirements. In Parkinson’s disease, the degeneration of the substantia nigra and the corresponding loss of dopamine production results in excessive GPi activity inhibiting the thalamus and reducing the thalamocortical activity resulting in akinesia and rigidity. High-frequency DBS suppresses the neuronal activity of GPi and activates the efferent fibre pathway.  

In DBS surgery, the correct placement of electrodes is guided by stereotactic frame-based imaging. Additional methods include localization (microelectrode recording MER and macrostimulation). Initially, the stimulation electrodes are placed, and electrical stimulation is passed to record the improvement in the motor activity in the patient to determine the most optimal electrode location. Side effects are also monitored at different stimulation strengths. After the location is determined, the stimulation electrodes are replaced with the permanent electrodes, which are activated after 1-2 weeks. Currently, preoperative levodopa responsiveness is the only predictor of postsurgical improvement after DBS. Neural activation induces an increase in regional cerebral blood flow (rCBF) and metabolism. Since the increase in regional cerebral blood flow exceeds the increase in tissue oxygen demands of activated brain tissue, the blood concentration of deoxy-Hb decreases while those of oxy-Hb and total-Hb increase.

Problem statement: There are many physiological changes described before and after activation of Insitu DBS electrodes - an increase in blood flow and changes in cerebral oxygenation corresponding with the improvement in motor activity. The changes during the placement and neurological testing are not studied due to limitations of surgical access, equipment and the confounding influence of anaesthetic agents. In this study, we will perform continuous regional cerebral oxygenation changes in the prefrontal area throughout the neurological testing and electrode placement. The observed changes and their impact on the postsurgical outcomes will be evaluated.

Hypothesis: We hypothesize that there will be improvement in the rSO2 values as early as during the neurological testing stimulation. The extent of the increase in rSO2 should correlate with the improvement in motor activity. This improvement in motor activity should also improve their pulmonary functions - either by improving muscle rigidity or improved coordination, resulting in a better test performance. There might be an improvement in cerebral blood flow velocities after DBS.   

 
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