RecruitingNot ApplicableNCT06920134

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

Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease


Sponsor

Ecole Polytechnique Fédérale de Lausanne

Enrollment

5 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether spinal cord electrical stimulation (a small device placed near the spine) can help manage dangerously low blood pressure when standing up — a condition called orthostatic hypotension — in people with Parkinson's disease and related conditions. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with Parkinson's disease or a related condition (like Multiple System Atrophy or Progressive Supranuclear Palsy) - You have confirmed orthostatic hypotension (blood pressure drops when you stand up) - This low blood pressure significantly disrupts your daily life - You can communicate in French or English **You may NOT be eligible if...** - You have a disease that makes spinal implant surgery unsafe - You have a serious infection or active cancer - You are pregnant - Your condition is unstable in ways that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEARC-IM Investigational System

Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.


Locations(1)

CHUV

Lausanne, Canton of Vaud, Switzerland

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NCT06920134


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