GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
NCT ID: NCT04571112
Last Updated: 2022-11-02
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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COMPLETED
NA
6 participants
INTERVENTIONAL
2017-12-04
2021-03-01
Brief Summary
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Detailed Description
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This phase-II double-blind cross-over pilot trial will investigate the motor and cognitive effects as well as the presence of adverse effects of combined NBM and GPi DBS. The main goal of this pilot trial is to demonstrate the feasibility and safety of the multi-targeting approach in 6 patients with PDD and disabling motor symptoms.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
* The outcomes assessor is blinded to the whether the NBM DBS is active to avoid bias while analyzing the data
Study Groups
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NBM ON
The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over.
The NBM ON arm will have constant NBM stimulation for 8 weeks.
NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)
This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks.
NBM OFF
The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over.
The NBM OFF arm will have NBM stimulation turned off for 8 weeks.
NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)
This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks.
Interventions
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NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)
This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks.
Eligibility Criteria
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Inclusion Criteria
2. PD fulfilling standard criteria for bilateral GPi DBS surgery
3. Patient's ability to provide informed consent and comply with study protocol.
Exclusion Criteria
2. Inability to be fluent in English.
3. Unstable dose of any cognitive enhancing medication.
4. Presence of other neurological disorders, severe active psychiatric conditions or previous brain surgery.
Other conditions contraindicating DBS, PET scanning or MRI scanning.
ALL
No
Sponsors
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University of Toronto
OTHER
Responsible Party
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Alfonso Fasano
Dr. Alfonso Fasano, MD, PhD, Professor, Department of Medicine, Division of Neurology at University of Toronto, Toronto Western Hospital
Principal Investigators
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Alfonso Fasano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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Other Identifiers
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17-5400-B
Identifier Type: -
Identifier Source: org_study_id
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