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
Plain-Language Summary
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.