Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
NCT ID: NCT03422757
Last Updated: 2020-11-19
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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TERMINATED
NA
6 participants
INTERVENTIONAL
2017-06-01
2018-12-30
Brief Summary
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The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.
Detailed Description
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Randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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adaptive DBS
adaptive Deep Brain Stimulation, by AlphaDBSvext.
adaptive Deep Brain Stimulation
The investigational medical device ("AlphaDBSvext") is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD.
In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal.
conventional DBS
conventional Deep Brain Stimulation, by AlphaDBSvext.
conventional Deep Brain Stimulation
The same investigational medical device ("AlphaDBSvext") is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation.
Interventions
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adaptive Deep Brain Stimulation
The investigational medical device ("AlphaDBSvext") is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD.
In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal.
conventional Deep Brain Stimulation
The same investigational medical device ("AlphaDBSvext") is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation.
Eligibility Criteria
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Inclusion Criteria
* DBS implant since at least 3 years and in need of battery replacement, defined by battery level \<25%;
* Patients must be able to sign the informed consent document to participate in the clinical trial;
* Patients with a suboptimal response to DBS treatment.
Exclusion Criteria
* Patients with major psychiatric issues;
* Patients with any medical condition potentially interfering with DBS battery replacement surgery;
* Patients that cannot tolerate an interruption of DBS stimulation;
* Patients taking only one levodopa dose per day;
* Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
* Pregnant or breastfeeding women.
18 Years
80 Years
ALL
No
Sponsors
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Newronika
INDUSTRY
Responsible Party
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Locations
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Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
Milan, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, , Italy
IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, , Italy
Countries
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Other Identifiers
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NWK_aDBSext_01_2017
Identifier Type: -
Identifier Source: org_study_id