AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease

RecruitingNAAges 18 Years - 90 YearsAllEcole Polytechnique Fรฉdรฉrale de Lausanne
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. \> 18 years old 2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy) 3. Confirmed orthostatic hypotension with a test for verticalization 4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians 5. Must provide and sign the Informed Consent before any study-related procedures 6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators; 7. Able to understand and interact with the study team in French or English 8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments Exclusion Criteria: 1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery 2. The inability to withhold antiplatelet/anticoagulation agents perioperatively 3. History of myocardial infarction or cerebrovascular events within the past 6 months 4. Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator 5. History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist 6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation) 7. Inability to follow study procedures. 8. Spinal anatomical abnormalities precluding surgery 9. Presence of any indications requiring frequent MRIs. 10. Current pregnancy or current breastfeeding 11. Lack of effective or acceptable contraception for women of childbearing capacity 12. Intention to become pregnant during the study 13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator 14. Participation in another interventional study that might confound study endpoint evaluations 15. Enrolment of the investigator, his/her family members, employees, and other dependent persons
๐Ÿ’Š

What it tests

  • ARC-IM Investigational System
๐Ÿ“

Where

1 site
CHUV
Lausanne, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy