Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
NCT06920134 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-11-18
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.
Conditions
- Hypotension Symptomatic
- Parkinson's Disease
- Orthostatic Hypotension, Dysautonomic
- Multiple System Atrophy (MSA) With Orthostatic Hypotension
- Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
Interventions
- DEVICE
-
ARC-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.
Sponsors & Collaborators
-
Ecole Polytechnique Fédérale de Lausanne
lead OTHER
Principal Investigators
-
Jocelyne Bloch, MD · CHUV
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-03
- Primary Completion
- 2031-05-01
- Completion
- 2031-05-01
Countries
- Switzerland
Study Locations
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