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Device

Deep Brain Stimulation for Parkinson's Disease (CANADA Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 months after ipg change, 8 months after battery change
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new type of brain stimulation for Parkinson's patients that adjusts itself automatically based on brain activity. It aims to help those who have symptoms like freezing of gait or trouble speaking, which are not well-treated by current methods. This new approach has been shown to be at least as effective as traditional methods, with reduced stimulation time and fewer side effects.

Who is the study for?
This trial is for Parkinson's disease patients with specific disabling gait, balance, or speech issues worsened by their current DBS treatment. Participants must need an IPG replacement, have a good LFP signal for adaptive DBS use, and be able to consent and follow the study plan. Those with severe non-motor problems like depression or dementia, unstable medical conditions, non-Medtronic DBS systems, or other disorders affecting outcomes can't join.
What is being tested?
The CANadian Adaptive DBS Trial is testing a new 'adaptive' deep brain stimulation (aDBS) against the standard continuous DBS (cDBS). It aims to see if aDBS can better improve speech and walking issues in Parkinson's patients by adjusting stimulation based on real-time brain signals.
What are the potential side effects?
While not explicitly listed here, potential side effects may include those typical of deep brain stimulation procedures such as headache, dizziness, bleeding in the brain, infection at the implant site; plus device-specific issues related to adaptive adjustments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2-5 months after ipg change, 8 months after battery change
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2-5 months after ipg change, 8 months after battery change for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II
Change in Gait using the Zeno Walkway by Protokinetics
Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)
+1 more
Secondary study objectives
Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)

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: Continuous DBSExperimental Treatment1 Intervention
Group II: Adaptive DBSActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous DBS
2014
N/A
~10

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
717 Previous Clinical Trials
1,042,407 Total Patients Enrolled

Media Library

Adaptive DBS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05402163 — N/A
Parkinson's Disease Research Study Groups: Continuous DBS, Adaptive DBS
Parkinson's Disease Clinical Trial 2023: Adaptive DBS Highlights & Side Effects. Trial Name: NCT05402163 — N/A
Adaptive DBS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05402163 — N/A
~5 spots leftby Jun 2025