Epidural electrical stimulation to support hemodynamic management in people with Parkinson's disease
Descrizione riassuntiva dello studio
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.
(BASEC)
Intervento studiato
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).
(BASEC)
Malattie studiate
Parkinson
(BASEC)
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)
Criteri di esclusione
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)
Luogo dello studio
Losanna
(BASEC)
Sponsor
Ecole Polytechnique Fédérale de Lausanne (EPFL)
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. Jocelyne Bloch
+41 79 556 89 79
neurorestore.studies@clutterchuv.chCentre Hospitalier Universitaire de Lausanne (CHUV)
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
22.05.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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