Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease
NCT ID: NCT02154724
Last Updated: 2014-06-03
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
20 participants
INTERVENTIONAL
2013-09-30
2015-09-30
Brief Summary
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Detailed Description
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Intracerebral activity analyzed by recording local field potentials (LFPs) from electrodes implanted for DBS in the past 15 years has helped in clarifying basal ganglia pathophysiology and its relation to PD symptoms. Many LFP studies have revealed unknown functions of basal ganglia in PD patients during the execution of motor, cognitive, and behavioral task showing the existence of a "code" in LFP oscillations corresponding to the of patient's clinical condition. LFP-clinical correlations should provide the rationale for developing and implementing new aDBS devices able to adapt stimulation parameters moment-by-moment to the individual patient's needs using LFPs as a control variable for feedback.
Conditions
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Study Design
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CROSSOVER
TREATMENT
DOUBLE
Study Groups
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aDBS
The aDBS (adaptive Deep Brain Stimulation) device is applied both in aDBS and in DBS modality, for two hours in random order for two days. The aDBS can be programmed to deliver aDBS controlled by local fields potential or conventional DBS.
aDBS
The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.
DBS
The aDBS s applied for two hous in DBS modality.
Interventions
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aDBS
The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.
DBS
The aDBS s applied for two hous in DBS modality.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Each patient affected by Parkinson's Disease and implanted with DBS electrodes, following the inclusion criteria of L.I.M.P.E., 2003
18 Years
70 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Locations
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy
Countries
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Central Contacts
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Other Identifiers
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ADBS-2013-IRCCSMaggioreH
Identifier Type: -
Identifier Source: org_study_id
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