---
title: Improve orthostatic blood pressure stability
nct_id: NCT06920134
phase: NA
status: RECRUITING
sponsor: Ecole Polytechnique Fédérale de Lausanne
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06920134"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06920134"
last_fetched: "2026-05-10T14:07:08.145Z"
source: "Parkinson's Pathways (curated)"
---
# Improve orthostatic blood pressure stability

**Goal (in five words):** Improve orthostatic blood pressure stability

**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

**Trial ID:** [NCT06920134](https://clinicaltrials.gov/study/NCT06920134)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Ecole Polytechnique Fédérale de Lausanne
- **Target Enrollment:** 5 participants
- **Start Date:** 2025-07-03
- **Completion Date:** 2031-05-01
- **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
- **Intervention Types:** DEVICE

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

1. \> 18 years old
2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)
3. Confirmed orthostatic hypotension with a test for verticalization
4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians
5. Must provide and sign the Informed Consent before any study-related procedures
6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;
7. Able to understand and interact with the study team in French or English
8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Exclusion Criteria:

1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
2. The inability to withhold antiplatelet/anticoagulation agents perioperatively
3. History of myocardial infarction or cerebrovascular events within the past 6 months
4. 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
5. 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
6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)
7. Inability to follow study procedures.
8. Spinal anatomical abnormalities precluding surgery
9. Presence of any indications requiring frequent MRIs.
10. Current pregnancy or current breastfeeding
11. Lack of effective or acceptable contraception for women of childbearing capacity
12. Intention to become pregnant during the study
13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator
14. Participation in another interventional study that might confound study endpoint evaluations
15. Enrolment of the investigator, his/her family members, employees, and other dependent persons
```

## Locations (1)

- CHUV, Lausanne, Canton of Vaud, Switzerland _(46.5160, 6.6328)_
  - Jocelyne Bloch — (CONTACT) — +41 79 556 2951 — jocelyne.bloch@chuv.ch

## Central Contacts

- Gregoire Courtine, PhD — (CONTACT) — +41 21 69 30762 — gregoire.courtine@epfl.ch

---

*Canonical: https://parkinsonspathways.com/trial/NCT06920134*  
*HTML version: https://parkinsonspathways.com/trial/NCT06920134*  
*Source data: https://clinicaltrials.gov/study/NCT06920134*