Epidural electrical stimulation to support hemodynamic management in people with Parkinson's disease
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Ecole Polytechnique Fédérale de Lausanne (EPFL)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. Jocelyne Bloch
+41 79 556 89 79
neurorestore.studies@clutterchuv.chCentre Hospitalier Universitaire de Lausanne (CHUV)
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
22.05.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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