Actively Recruiting
CANadian Adaptive DBS TriAl
Led by University of Toronto · Updated on 2024-07-18
10
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS). This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.
CONDITIONS
Official Title
CANadian Adaptive DBS TriAl
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parkinson's disease treated with bilateral STN DBS using Medtronic lead
- Ability to provide informed consent and follow study protocol
- Need to replace implantable pulse generator due to battery end of life
- Presence of disabling gait, balance, or speech issues judged by doctor and patient
- Evidence these issues improve when DBS is turned off
- Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other
- Good local field potential signal in at least one hemisphere after IPG replacement
You will not qualify if you...
- Previous DBS surgery without Medtronic products
- Use of therapeutic stimulation configurations (e.g., bipolar) preventing adaptive DBS use
- Other disorders impacting outcomes (e.g., orthopedic problems)
- Medically unstable condition
- Severe non-motor issues such as depression or dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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