← Back to Search

Procedure

Advanced DBS Programming for Parkinson's Disease

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and first programming (baseline) - crossover programming (1 month follow-up)- third month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patients' Global Impression of Change (PGIC) scale

Secondary outcome measures

MDS-UPDRS-III

MDS-UPDRS-IV

The Parkinson's Disease Questionnaire (PDQ-39)

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

690 Previous Clinical Trials

1,019,623 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this research project?

"According to clinicaltrials.gov, this study is still recruiting patients and has been since the initial posting on September 29th 2023. The listing was most recently revised on November 6th of the same year."

Answered by AI

What is the participant number for this scientific investigation?

"Affirmative. As seen on clinicaltrials.gov, enrollment for this medical trial is ongoing and began on September 29th 2023. The most recent update was made November 6th 2023 and the study requires a total of 20 participants to be recruited from one site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Unblocking the Full Potential of Percept PC IPG

Alfonso Fasano 2023. "Effects of Unblocking the Full Potential of Percept PC IPG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06127771.