Algorithm Guided DBS Programming in Parkinson's Patients

Parkinson Disease Clinical Trial

Official title:

Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205043
• Other study ID #: Stimulation Search
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Jaslok Hospital and Research Centre
• Contact: Paresh Doshi, MCh
• Phone: +91 9820063854
• Email: pareshkd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• StimSearch programming algorithm software
This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease
• Clinician based programming
This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease

Locations

Country	Name	City	State
India	Jaslok Hospital And Research Centre	Mumbai	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Jaslok Hospital and Research Centre	Boston Scientific Corporation

Country where clinical trial is conducted

India, 

References & Publications (3)

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 — View 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.parkr — View 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, Randomiz — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Comparison of time required between StimSearch and SOC programming	Total time in minutes will recorded	4 weeks
Secondary	Comparison of volume of tissue activated (VTA) between StimSearch and SOC	The volume of tissue activated in cubic millimeter will be calculated.	4 weeks
Secondary	Comparison of target volume between StimSearch and SOC	The target volume in cubic millimeter will be calculated.	4 weeks