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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Patients undergoing Deep Brain Stimulation for Parkinson's disease will be subjected to standard of care programming and compared with the algorithm based programming (StimSearch). Various parameters including the effectivity and efficiency of algorithm programming will be compared against the standard of care programming.
Patients of Parkinson's disease undergoing bilateral subthalamic nucleus stimulation (STN), we have already been adequately programmed and have achieved good outcome, will undergo an exploratory study to evaluate the effectiveness of algorithm based programming (Phase 1). Subsequently, patients undergoing STN DBS will be randomly allocated to algorithm based programming/ standard of care programming and after adequate stabilisation evaluated for motor improvement. They will be switched over to the alternative technique of programming and evaluated again after a similar period. Data regarding the time consumed, effectivity and several secondary endpoints will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care (SoC) based programming in Parkinson's disease patients | Active Comparator | Patients will be programmed in a routine (Standard of Care) program. Based on the randomization the patient may receive this at the beginning or after the Stim search program (crossover) |
|
| StimSearchTM software based programing in Parkinson's disease patients | Experimental | Patients will be programmed using StimSearch algorithm. Based on the randomization the patient may receive this at the beginning or after the Standard of Care program (crossover) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimSearch programming algorithm software | Device | This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming. | Unified Parkinson's disease rating scale scores (part III) will be used to evaluate this. Range (0-132) The lower the score indicates lesser severity of the disease and improved outcome. | 4 weeks |
| Comparison of time required between StimSearch and SOC programming | Total time in minutes will recorded | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of volume of tissue activated (VTA) between StimSearch and SOC | The volume of tissue activated in cubic millimeter will be calculated. | 4 weeks |
| Comparison of target volume between StimSearch and SOC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paresh Doshi, MCh | Contact | +91 9820063854 | pareshkd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paresh Doshi, MCh | Jaslok Hospital and Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaslok Hospital And Research Centre | Recruiting | Mumbai | Maharashtra | 400026 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35790135 | Result | Malekmohammadi M, Mustakos R, Sheth S, Pouratian N, McIntyre CC, Bijanki KR, Tsolaki E, Chiu K, Robinson ME, Adkinson JA, Oswalt D, Carcieri S. Automated optimization of deep brain stimulation parameters for modulating neuroimaging-based targets. J Neural Eng. 2022 Jul 20;19(4):10.1088/1741-2552/ac7e6c. doi: 10.1088/1741-2552/ac7e6c. | |
| 33556765 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Patients will be randomized to receive either an algorithm based program vs standard of care program. After a period each group will cross over to the other side. UPDRS assessments will be done at each time.
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| Clinician based programming | Device | This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease |
|
The target volume in cubic millimeter will be calculated.
| 4 weeks |
| Sasaki F, Oyama G, Sekimoto S, Nuermaimaiti M, Iwamuro H, Shimo Y, Umemura A, Hattori N. Closed-loop programming using external responses for deep brain stimulation in Parkinson's disease. Parkinsonism Relat Disord. 2021 Mar;84:47-51. doi: 10.1016/j.parkreldis.2021.01.023. Epub 2021 Jan 30. |
| 34151855 | Result | Wenzel GR, Roediger J, Brucke C, Marcelino ALA, Gulke E, Potter-Nerger M, Scholtes H, Wynants K, Juarez Paz LM, Kuhn AA. CLOVER-DBS: Algorithm-Guided Deep Brain Stimulation-Programming Based on External Sensor Feedback Evaluated in a Prospective, Randomized, Crossover, Double-Blind, Two-Center Study. J Parkinsons Dis. 2021;11(4):1887-1899. doi: 10.3233/JPD-202480. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |