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
62 participants
INTERVENTIONAL
2021-06-09
2024-12-31
Brief Summary
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All participants will undergo bilateral implant in the subthalamic nucleus (STN) and data collected in common practice will be recorded during six months post-implant and analyzed.
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Detailed Description
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Subjects selected to participate in the study will be Parkinson's Disease (PD) patients who are eligible for bilateral DBS for STN therapy and meet the inclusion criteria and none of the exclusion criteria.
Primary safety and effectiveness endpoints data will be collected through 6 months of follow-up. The values used for comparison are derived from a review of literature spanning from 2001 to 2019.
After completing the 6 month follow-up, subject will exit the study, and continue to be followed by their physician per usual care.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deep Brain Stimulation
Patients will undergo bilateral implant of directSTIM system in the STN.
Deep Brain Stimulation
Patients with PD who are eligible to bilateral STN DBS surgery and chose to get directSTIM System implanted will be followed over a 6-month period to evaluate changes in their condition.
Interventions
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Deep Brain Stimulation
Patients with PD who are eligible to bilateral STN DBS surgery and chose to get directSTIM System implanted will be followed over a 6-month period to evaluate changes in their condition.
Eligibility Criteria
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Inclusion Criteria
* Patient is eligible for bilateral DBS for STN therapy according to center's routine criteria and according to the directSTIM DBS system Indications for Use statement.
* Patient who is willing to provide a written informed consent.
* Patient complies with the study follow-up, in particular the follow-up visits, and other study requirements.
Exclusion Criteria
* Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to complete study assessments, such as:
* Active major psychiatric disorder.
* Dementia (MoCa Dementia Rating Scale score \<26 or otherwise not capable of discernment).
* Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker).
* Previous surgery for the treatment of Parkinson's disease.
* Previous brain ablation procedure.
* Epilepsy.
* Coagulopathies.
* Abuse of drugs or alcohol.
* Patient is participating in another clinical study that would confound data analysis.
* Patient is pregnant or nursing. As for other DBS systems, the effects of the device on an unborn child are not established.
18 Years
ALL
No
Sponsors
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Aleva Neurotherapeutics SA
INDUSTRY
Responsible Party
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Principal Investigators
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Alain Dransart
Role: STUDY_DIRECTOR
Aleva Neurotherapeutics SA
Locations
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Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Schleswig-Holstein (Kiel)
Kiel, , Germany
Universitätsklinikum Münster
Münster, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLI-12011
Identifier Type: -
Identifier Source: org_study_id
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