Study Results
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View full resultsBasic Information
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COMPLETED
17 participants
OBSERVATIONAL
2017-03-29
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Interventions
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SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Eligibility Criteria
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Inclusion Criteria
* Subject is ≥ 18 and ≤ 74 years of age;
* Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus (STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigator's opinion;
* In the physician's opinion, the subject is a suitable candidate for an IPG replacement with different stimulation paradigm;
* Subject needs and/or requests an IPG replacement within 12 months after consent and the current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment;
* PD symptom onset is no longer than 20 years;
* Subject has a Hoehn \& Yahr score \<IV (on stim);
* Subject with a normal cognitive function (MMSE ≥25);
* Subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located.
Exclusion Criteria
* Need to replace or reposition the leads or extensions during the IPG replacement procedure;
* Subject had \>10 recurrent falls experienced in the 3 months prior to consent;
* Subject is unwilling to change to either a St Jude Medical Infinity™ or Brio™ DBS system for the IPG replacement;
* Subject is unable to attend the study visits.
18 Years
74 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Karst
Role: STUDY_DIRECTOR
Abbott
Locations
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Baptist Hospital of Miami
Kendall, Florida, United States
Neuroscience Consultants
Miami, Florida, United States
Albany Medical College at Albany Medical Ctr
Albany, New York, United States
Praxis Dr. Oehlwein
Gera, , Germany
Klinik am Tharandter Wald
Halsbrücke, , Germany
Universitätsklinikum Leipzig AÖR
Leipzig, , Germany
Az.Osp. Universitaria Ferrara
Ferrara, Cona, Italy
Fondazione "Ospedale San Camillo" I.R.C.C.S
Padua, Veneto, Italy
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, , Italy
Ospedale dell'Angelo
Mestre, , Italy
IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia, , Italy
Policlinico Universitario A. Gemelli
Roma, , Italy
Azienda Ospedaliero-Universitaria S Maria della Misericordia
Udine, , Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10135
Identifier Type: -
Identifier Source: org_study_id
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