Cycling Deep Brain Stimulation on Parkinson's Disease Gait
NCT ID: NCT04408573
Last Updated: 2020-06-23
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-06-19
2021-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Regular Continuous High Frequency
Patient remains 2 weeks in the currently chosen stimulation protocol.
No interventions assigned to this group
Cycling High Frequency
Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF
Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Continuous Low Frequency
Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Cycling Low Frequency
Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Interventions
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Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Eligibility Criteria
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Inclusion Criteria
* Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
* Hoehn \& Yahr stage between 2-4 during off-medication
* Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
* Willingness to comply with all study procedures
Exclusion Criteria
* Active infection or other uncontrolled moderate/grave comorbidities
* Treatment with experimental drug
* Pregnancy or breast-feeding
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Rubens Gisbert Cury
Principal Investigator
Principal Investigators
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Rubens G Cury, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo General Hospital
Locations
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Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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67914017.6.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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