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New treatment option for Hypotension Symptomatic
Official title Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
ClinicalTrials.gov ID: NCT06920134
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- \> 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
You likely can't join if
- 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...
- History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the...
- Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)
See the full eligibility criteria
- \> 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
- 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 treatment study that might confound study endpoint evaluations
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.