Clinical trial NCT06205043: Algorithm Guided DBS Programming in Parkinson's Patients
Official title: Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep brain stimulation
Programming
Parkinson disease
Lead sponsor: Jaslok Hospital and Research Centre
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-01-12
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of bilateral idiopathic Parkinson's disease
* Exhibit a UPDRS subset III score of ≥ 25 while in the preoperative medication off state
* Demonstrate an improvement of Parkinson's disease symptoms by ≥30% in the medication off state following a pre-operative levodopa challenge, as assessed by the UPDRS subset III score
* Possess the ability to comprehend the study's demands, treatment protocols, and procedures, and provide written informed consent before undergoing any study-specific tests or procedures

Exclusion Criteria:

* Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.

Primary outcomes:
measure: Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.
timeFrame: 4 weeks
measure: Comparison of time required between StimSearch and SOC programming
timeFrame: 4 weeks
Secondary outcomes:
measure: Comparison of volume of tissue activated (VTA) between StimSearch and SOC
timeFrame: 4 weeks
measure: Comparison of target volume between StimSearch and SOC
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Jaslok Hospital And Research Centre
state: Maharashtra
Study officials:
affiliation: Jaslok Hospital and Research Center
name: Paresh Doshi, MCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.