Your session is about to expire
← Back to Search
Procedure
Advanced DBS Programming for Parkinson's Disease
N/A
Waitlist Available
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals with idiopathic Parkinson's disease who previously underwent DBS surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first programming (baseline) - crossover programming (1 month follow-up)- third month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the effectiveness of a newer neurostimulator vs. an older one for people with Parkinson's Disease, with 3 clinic visits over 1 year. Primary outcome is patient-reported global impression of change (PGIC).
Who is the study for?
This trial is for Parkinson's disease patients who've had Deep Brain Stimulation (DBS) surgery and upgraded their neurostimulator from Activa PC to Medtronic PerceptTM PC. Participants must be able to give informed consent.
What is being tested?
The study tests the effectiveness of programming DBS with the full capabilities of the Percept PC neurostimulator compared to older settings. It's a double-blinded, randomized, cross-over trial involving three clinic visits over one year.
What are the potential side effects?
While specific side effects are not listed, reprogramming a neurostimulator may cause temporary discomfort or changes in motor symptoms until optimal settings are found.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Parkinson's and had DBS surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first programming (baseline) - crossover programming (1 month follow-up)- third month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first programming (baseline) - crossover programming (1 month follow-up)- third month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patients' Global Impression of Change (PGIC) scale
Secondary study objectives
MDS-UPDRS-III
MDS-UPDRS-IV
The Parkinson's Disease Questionnaire (PDQ-39)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Percept PC programmingExperimental Treatment1 Intervention
Individuals' DBS will be programmed using the full capacity of Percept PC IPG.
Group II: Standard of Care programmingActive Control1 Intervention
Individuals' DBS will be programmed using SOC programming parameters.
Find a Location
Who is running the clinical trial?
University of TorontoLead Sponsor
725 Previous Clinical Trials
1,115,677 Total Patients Enrolled