Effects of Unblocking the Full Potential of Percept PC IPG

October 31, 2024 updated by: Alfonso Fasano, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Movement Disorders Centre - Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care programming
Individuals' DBS will be programmed using SOC programming parameters.
Experimental: Percept PC programming
Individuals' DBS will be programmed using the full capacity of Percept PC IPG.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Global Impression of Change (PGIC) scale
Time Frame: 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.
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
Time Frame: 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.
First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
MDS-UPDRS-IV
Time Frame: 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.
First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
The Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 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.
First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2023

Primary Completion (Actual)

December 13, 2023

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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