| CTRI Number |
CTRI/2025/05/087502 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Improving surgical treatment (Deep Brain Stimulation) of Parkinsons Disease, Dystonia, Depression, Obsessive-Compulsive Disorder and Tourettes Syndrome (Tics). |
|
Scientific Title of Study
|
Tractography-based Targeting and Programming of Deep Brain Stimulation for Neurological and Psychiatric Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Neurosurgery and Stereotactic and Functional Neurosurgery |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Neurosciences, 11th Floor South, Jaslok Hospital and Research Center, 15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026, India 15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026, India Mumbai MAHARASHTRA 400026 India |
| Phone |
919930960960 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Neurosurgery and Stereotactic and Functional Neurosurgery |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Neurosciences, 11th Floor South, Jaslok Hospital and Research Center, 15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026, India 15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026, India Mumbai MAHARASHTRA 400026 India |
| Phone |
919930960960 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Neurosurgery and Stereotactic and Functional Neurosurgery |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Neurosciences, 11th Floor South, Jaslok Hospital and Research Center, 15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026, India 15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026, India Mumbai MAHARASHTRA 400026 India |
| Phone |
919930960960 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaslok Hospital and Research Center |
|
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Primary Sponsor
|
| Name |
Jaslok Hospital and Research Centre |
| Address |
15, Dr G Deshmukh Marg, Mumbai, Maharashtra-400026 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Paresh K Doshi |
Jaslok Hospital and Research Centre |
Department of Neurosciences, 11th Floor South, 15 Dr. G Deshmukh Marg Mumbai MAHARASHTRA |
9930960960
pareshkd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jaslok Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Jaslok Hospital and Research Centre |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, (2) ICD-10 Condition: G24||Dystonia, (3) ICD-10 Condition: F34||Persistent mood [affective] disorders, (4) ICD-10 Condition: F42||Obsessive-compulsive disorder, (5) ICD-10 Condition: F95||Tic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct targeting of Deep Brain Stimulation (DBS) electrodes and standard of care programming of Implantable Pulse Generator (IPG) |
The patient will undergo Magnetic Resonance Imaging (MRI) as per our Deep Brain Stimulation (DBS) protocol. Additionally, the patient will undergo a Diffusion Tensor Imaging (DTI) Scan that will be used for tractography. The Consultant Neurosurgeon will then identify the most suitable target for each patient: 1) by direct targeting and one of the co-investigator neurosurgeon will identify the 2) tractography-based target. For tractography-based targeting, a combination of FSL and BRAINLab planning algorithms will be used. Here, we will select the point (region of the target) with the maximum probability of the tract of interest (known to provide relief for the most prominent symptoms of the patient) passing through it. The final target for the procedure will be selected such that the electrode passes through both the targets (direct target and tractography-based target). In case there is no possible trajectory to include both targets, the patient will be excluded from further analysis under the current project. Once the target is finalized, DBS surgery will be performed as per the standard procedure. After the surgery, the IPG will also be programmed based on two approaches -
1. Standard of Care - Here, the pacemaker is initially programmed as per its anatomical relations with the target (eg. STN). Thereafter, the program is altered as per clinical examination (eg. rigidity, bradykinesia, and tremors) by an expert and feedback from the patient. The aim is to achieve maximum relief with minimum adverse effects.
2. Tractography
After four weeks, the patient will be switched over to the other type of programming. To minimize bias, the order of programming techniques will be randomized and the assessor will not be informed about the program the patient is given.
|
| Intervention |
Tractography-based targeting of Deep Brain Stimulation electrodes and programming of Implantable Pulse Generator |
The patient will undergo Magnetic Resonance Imaging (MRI) as per our Deep Brain Stimulation (DBS) protocol. Additionally, the patient will undergo a Diffusion Tensor Imaging (DTI) Scan that will be used for tractography. The Consultant Neurosurgeon will then identify the most suitable target for each patient: 1) by direct targeting and one of the co-investigator neurosurgeon will identify the; 2) tractography-based target. For tractography-based targeting, a combination of FSL and BRAINLab planning algorithms will be used. Here, we will select the point (region of the target) with the maximum probability of the tract of interest (known to provide relief for the most prominent symptoms of the patient) passing through it. The final target for the procedure will be selected such that the electrode passes through both the targets (direct target and tractography-based target). In case there is no possible trajectory to include both targets, the patient will be excluded from further analysis under the current project. Once the target is finalized, DBS surgery will be performed as per the standard procedure. After the surgery, the IPG will also be programmed based on two approaches -
1. Standard of Care
2. Tractography-based - The most prominent symptom of the patient will be identified, and the tract reported to provide maximum clinical benefit for that symptom will be localized and stimulated. Minor changes will be made in the program based on clinical examination and patient feedback to achieve the best response.
After four weeks, the patient will be switched over to the other type of programming. To minimize bias, the order of programming techniques will be randomized and the assessor will not be informed about the program the patient is given.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Population - Patients diagnosed with Parkinson’s Disease, Dystonia, Depression, Obsessive-Compulsive Disorder, or Tourette Syndrome as per International Classification of Diseases (ICD)-10, unresponsive to the standard of care pharmacotherapy for at least 6 months.
Inclusion and Exclusion Criteria -
- The patient must be fit for general anesthesia (without or with ongoing medications).
- The patient must meet specific diagnostic criteria for undergoing DBS: 1) as per the core Assessment Program for Surgical Interventional Therapies in Parkinson’s Disease (CAPSIT-PD) for Parkinson’s Disease and 2) Disease severity “severe” as per clinical assessment for other pathologies. |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anatomical difference between the direct and tractography-based DBS targets |
Within 15 days of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in the clinical efficacy of standard of care and tractography-based programming of the Implantable Pulse Generator |
1 month after IPG Programming |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pareshkd@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Introduction - Tractography is emerging as a precise and more personalized approach for DBS targeting and programming, especially given the evolving understanding of the physiological mechanisms underlying the therapeutic benefits of DBS. The advances in imaging and post-processing software have further influenced the interest in exploring the role of tractography. We plan to investigate the role of tractography in defining the DBS target, its correlation with the conventional targeting techniques and finally deciding if one is better than the other.
Different regions of the cortex connect differently to the target nuclei, and though there is a good amount of conformity, there is also significant variability in the areas connected. This, in turn, influences the clinical responses in the patient seen during programming. We plan to investigate the preoperative tractography-based information and use it to perform postoperative programming, especially in difficult cases of dystonia, psychiatric disorders, or Parkinson’s disease. Lastly, we intend to advocate for precision-targeting with evidence from a cohort of Indian patients.
Methodology - Patients with Parkinson’s Disease, Dystonia, Depression, Obsessive-Compulsive Disorder, and Tourette Syndrome, eligible for Deep Brain Stimulation (based on standard guidelines), will be enrolled in the study. Two investigators will independently locate direct and tractography-based targets. Attempts will be made to include both targets in the trajectory. If not, the electrode will be implanted as per the direct target. Each patient’s pacemaker will then be programmed as per clinical assessment and tracking based on one month, each with regular clinical assessments. The outcome between the two methods would be compared. |