RecruitingNot ApplicableNCT06920134
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
Sponsor
Ecole Polytechnique Fédérale de Lausanne
Enrollment
5 participants
Start Date
Jul 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 90 Years
Inclusion Criteria8
- \> 18 years old
- Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)
- Confirmed orthostatic hypotension with a test for verticalization
- Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians
- Must provide and sign the Informed Consent before any study-related procedures
- Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;
- Able to understand and interact with the study team in French or English
- Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
Exclusion Criteria15
- Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
- The inability to withhold antiplatelet/anticoagulation agents perioperatively
- History of myocardial infarction or cerebrovascular events within the past 6 months
- 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
- 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
- Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)
- Inability to follow study procedures.
- Spinal anatomical abnormalities precluding surgery
- Presence of any indications requiring frequent MRIs.
- Current pregnancy or current breastfeeding
- Lack of effective or acceptable contraception for women of childbearing capacity
- Intention to become pregnant during the study
- Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator
- Participation in another interventional study that might confound study endpoint evaluations
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
Interventions
DEVICEARC-IM Investigational System
Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06920134
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