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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2-5 months after ipg change, 8 months after battery change
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2-5 months after ipg change, 8 months after battery change
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 moreSecondary 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
719 Previous Clinical Trials
1,042,542 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe mental health issues like depression or dementia.You are using a specific type of electrical stimulation that would interfere with the study treatment.I'm sorry, but this criterion seems to be incomplete or unclear. It's difficult to provide a plain and simple explanation without more context or details. If you can provide more information or clarify the criterion, I'd be happy to help.You need to replace the device that sends electrical pulses to your body because the battery is running out of power.Your walking, balance, or speech problems get worse when the deep brain stimulation (DBS) is turned on, and get better when it's turned off.The brain signal can be measured accurately after a specific device is replaced with another one.You had deep brain stimulation surgery, but it did not use Medtronic products.You have other health problems that could affect the study results, like bone or joint issues.You have been treated for Parkinson's disease with a specific type of brain stimulation using a Medtronic lead.You have trouble walking, balancing, or speaking, as determined by the doctor and yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous DBS
- Group 2: Adaptive DBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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