Trials / Recruiting
RecruitingNCT06920134
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Ecole Polytechnique Fédérale de Lausanne · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-07-03
- Primary completion
- 2031-05-01
- Completion
- 2031-05-01
- First posted
- 2025-04-09
- Last updated
- 2025-11-18
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT06920134. Inclusion in this directory is not an endorsement.