Improve orthostatic blood pressure stability
- Trial ID
- NCT06920134
- Official Title
- Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
- Goal
- Improve orthostatic blood pressure stability
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Study Type
- INTERVENTIONAL
- Enrollment
- 5 participants
- Conditions
- Hypotension Symptomatic, Parkinson's Disease, Orthostatic Hypotension, Dysautonomic, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
- Interventions
- ARC-IM Investigational System
Summary For Families
The goal is to reduce symptomatic orthostatic hypotension that causes dizziness, fainting, and limits daily activities in people with typical or atypical Parkinsonism. The approach uses the ARC-IM investigational system, an implantable device placed during surgery that supports hemodynamic control by modulating autonomic signals or providing targeted stimulation to help maintain blood pressure when standing, working alongside your usual Parkinson’s medications rather than replacing them. Eligible participants are adults 18 to 90 with confirmed, functionally significant orthostatic hypotension and a diagnosis of typical or atypical PD (including MSA and similar conditions), who can undergo surgery, speak French or English, and meet safety criteria such as no recent major cardiac or cerebrovascular events and not being pregnant. It is an early safety and efficacy study with very limited enrollment, focused on whether the device can be safely implanted and help stabilize blood pressure.
Locations
- CHUV, Lausanne, Canton of Vaud, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying ARC-IM Investigational System. The goal is to reduce symptomatic orthostatic hypotension that causes dizziness, fainting, and limits daily activities in people with typical or atypical Parkinsonism. The approach uses the ARC-IM investigational system, an implantable device placed during surgery that supports hemodynamic control by modulating autonomic signals or providing targeted stimulation to help maintain blood pressure when standing, working alongside your usual Parkinson’s medications rather than replacing them. Eligible participants are adults 18 to 90 with confirmed, functionally significant orthostatic hypotension and a diagnosis of typical or atypical PD (including MSA and similar conditions), who can undergo surgery, speak French or English, and meet safety criteria such as no recent major cardiac or cerebrovascular events and not being pregnant. It is an early safety and efficacy study with very limited enrollment, focused on whether the device can be safely implanted and help stabilize blood pressure.
- Who can participate?
- Participants must be between 18 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 10 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.