Clinical trial NCT06127771: Effects of Unblocking the Full Potential of Percept PC IPG
Official title: Examining the Effects of Unblocking the Full Potential of Medtronic PerceptTM PC IPG on Symptoms of Individuals with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Patients' Global Impression of Change (PGIC) scale
timeFrame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
Secondary outcomes:
measure: MDS-UPDRS-III
timeFrame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
measure: MDS-UPDRS-IV
timeFrame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
measure: The Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Movement Disorders Centre - Toronto Western Hospital
state: Ontario
Study officials:
References: