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

Korábbi kezelés

• Spinal anatomical abnormalities precluding surgery

Más betegség

• Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
• 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

Egyéb

• The inability to withhold antiplatelet/anticoagulation agents perioperatively
• 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.
• 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

• > 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