Effects of Unblocking the Full Potential of Percept PC IPG

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Programming DBS using Percept PC neurostimulator's full potential

• Registration Number: NCT06127771
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-29
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Primary Completion: 2023-12-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-31
• Study Completion: 2024-11-01
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Percept PC programming	Programming DBS using Percept PC neurostimulator's full potential	Individuals' DBS will be programmed using the full capacity of Percept PC IPG.

Primary Outcome Measures

Name	Time	Method
Patients' Global Impression of Change (PGIC) scale	First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
The Parkinson's Disease Questionnaire (PDQ-39)	First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up	the investigators expect to see an improvement in PDQ-39. 0 to 100; being the higher the score, the worse the quality of life.
MDS-UPDRS-III	First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up	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.
MDS-UPDRS-IV	First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up	the investigators expect to see an improvement in the MDS-UPDRS-IV. The score ranges from 0-24. Higher scores indicate more severe impairment.

Trial Locations

Locations (1)

Movement Disorders Centre - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada