Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-06-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Continuous DBS
Continuous DBS
aDBS vs cDBS
Adaptive DBS
Adaptive DBS
aDBS vs cDBS
Interventions
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Adaptive DBS
aDBS vs cDBS
Continuous DBS
aDBS vs cDBS
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent and comply with study protocol
* Need to replace the implantable pulse generator (IPG) due to battery end of life
* Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
* Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
* Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one
* Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere
Exclusion Criteria
* Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
* Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
* Medically unstable
* Severe non-motor problems, such as depression, dementia, etc.
18 Years
80 Years
ALL
No
Sponsors
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University of Toronto
OTHER
Responsible Party
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Alfonso Fasano
Professor - University of Toronto
Locations
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Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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17-5527
Identifier Type: -
Identifier Source: org_study_id
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