Effects of Unblocking the Full Potential of Percept PC IPG

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127771
• Other study ID #: 23-5697
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: September 29, 2024

Study information

• Verified date: November 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Programming DBS using Percept PC neurostimulator's full potential
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.

Locations

Country	Name	City	State
Canada	Movement Disorders Centre - Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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