Effects of Unblocking the Full Potential of Percept PC IPG

Study Overview
=================
Brief Summary
-----------------
Population Size and Eligible Patients: The study will enroll patients with Parkinson's disease (n=30) who had an IPG replacement from Activa PC (older generation of neurostimulator) to Medtronic PerceptTM PC (newer generation of neurostimulator) as a part of their standard-of-care. No patient will be receiving the system for research purposes only. Study Design: This is a prospective, double-blinded, randomized, cross-over clinical investigation to further investigate the efficiency of Medtronic PerceptTM PC neurostimulator. This study involves three in clinic visits. During the first study visit, the patients' neurostimulator will be reprogrammed using all the additional features the Percept PC has to offer. At the end of the visit, the patients will be randomized between their baseline program, ((Activa PC group) and the newly defined programming settings (Percept Group). During the second visit (1-month follow-up) the effect will be clinically assessed, and a crossover of the condition will happen. The third visit (2-month follow-up) will be a follow-up visit with no programming but only clinical assessment. Study Duration: Expected study duration is 1 year with the possibility for renewals. Objectives and outcome measures: The goal is the study is to define whether or what the benefit is of the Percept PC neurostimulator compared to the older Activa PC neurostimulator. The primary outcome is patient-reported global impression of change (PGIC). The secondary outcome measures are clinical scales assessing symptoms of Parkinson's disease (UPDRS-III and -IV) and quality of life (PDQ-39), the active problems list and amount of medication intake.

Official Title
-----------------
Examining the Effects of Unblocking the Full Potential of Medtronic PerceptTM PC IPG on Symptoms of Individuals With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Programming DBS using Percept PC neurostimulator's full potential


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with idiopathic Parkinson's disease who previously underwent DBS surgery. Individuals who had IPG replacement from Activa PC to Medtronic PerceptTM PC Neurostimulator as standard-of-care Individuals should be able to provide their informed consent Exclusion Criteria: Cognition impairment (MoCA < 20/30) Patients with severe PD symptoms who are unable to come to the clinic three times within three months (e.g. bedridden patients)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care programming<br>Individuals' DBS will be programmed using SOC programming parameters. | |
| Experimental: Percept PC programming<br>Individuals' DBS will be programmed using the full capacity of Percept PC IPG. | Other: Programming DBS using Percept PC neurostimulator's full potential<br>* This study aims to enroll patients who previously had Activa PC neurostimulator and underwent a battery change to Medtronic PerceptTM PC as standard-of-care. However, in this study, the investigators intent to fully utilize the programming potential of Medtronic PerceptTM PC to optimize treatment outcome.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Global Impression of Change (PGIC) scale | the investigators expect to see an improvement of PGIC due to a decrease in (the severity of) active problems. The PGIC scale ranges from 1 to 7, with 1 indicating no change and 7 signifying a substantial improvement. | First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDS-UPDRS-III | the investigators expect to see an improvement in the MDS-UPDRS-III. Part III: Motor examination: 0 to 132, with higher scores indicating greater motor impairment. | First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up | 
| MDS-UPDRS-IV | the investigators expect to see an improvement in the MDS-UPDRS-IV. The score ranges from 0-24. Higher scores indicate more severe impairment. | First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up | 
| The Parkinson's Disease Questionnaire (PDQ-39) | the investigators expect to see an improvement in PDQ-39. 0 to 100; being the higher the score, the worse the quality of life. | First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up |