Epidural electrical stimulation to support hemodynamic management in people with Parkinson's disease
Summary description of the study
This study aims to evaluate the safety of the ARC-IM therapy, designed to electrically stimulate the spinal cord circuits involved in blood pressure regulation. This therapy aims to help individuals with typical or atypical Parkinson's disease better manage sudden fluctuations in blood pressure. The study will also assess the effectiveness of ARCIM therapy in improving blood pressure management, both in the short and long term, during tests where participants transition from a lying position to a standing position. It will also examine whether this therapy can enhance physical activity, particularly walking, balance, and mobility, as well as the ease of use of the ARCIM system for clinicians and patients. Other objectives include studying the effects of the therapy on increasing blood flow to the brain, reducing hypertension in the lying position, improving participants' quality of life, and its effectiveness as a complement to standard treatments, such as medications or deep brain stimulation.
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Intervention under investigation
The study intervention consists of 6 phases preceded by a pre-selection: Eligibility (E), Reference (B), Surgery (S), Configuration Phase (M), Home Use Phase (HU), and End of Study (EOS).
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Disease under investigation
Parkinson
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1. > 18 years old 2. Typical or atypical Parkinson's disease (including, but not limited to, multiple system atrophy, pure autonomic failure, progressive supranuclear palsy). 3. Confirmed and symptomatic orthostatic hypotension (BASEC)
Exclusion criteria
1. Diseases and conditions that would increase morbidity and mortality from implantation surgery 2. Contraindication to antiplatelet or anticoagulant therapy during the perioperative period 3. History of myocardial infarction or cerebrovascular events in the last 6 months (BASEC)
Trial sites
Lausanne
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Sponsor
Ecole Polytechnique Fédérale de Lausanne (EPFL)
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Contact
Contact Person Switzerland
Prof. Dr. Jocelyne Bloch
+41 79 556 89 79
neurorestore.studies@clutterchuv.chCentre Hospitalier Universitaire de Lausanne (CHUV)
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Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
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Date of authorisation
22.05.2025
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ICTRP Trial ID
not available
Official title (approved by ethics committee)
Study on preliminary safety and efficacy of the ARC-IM Therapy to support hemodynamic management in in people with typical and atypical Parkinson’s Disease. (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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