Parkinson Disease
Conditions
Keywords
Deep brain stimulation, Programming, Parkinson disease
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.
Interventions
DEVICEStimSearch programming algorithm software
This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease
DEVICEClinician based programming
This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease
Sponsors
Boston Scientific Corporation
Jaslok Hospital and Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming. | 4 weeks | 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. |
| Comparison of time required between StimSearch and SOC programming | 4 weeks | Total time in minutes will recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of volume of tissue activated (VTA) between StimSearch and SOC | 4 weeks | The volume of tissue activated in cubic millimeter will be calculated. |
| Comparison of target volume between StimSearch and SOC | 4 weeks | The target volume in cubic millimeter will be calculated. |
Countries
India
Contacts
Primary ContactParesh Doshi, MCh
Outcome results
None listed