| 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
|
|
|
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
|
|
|
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. |