Actively Recruiting
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-11-18
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of ARC-IM Therapy, which uses Epidural Electrical Stimulation, to help manage blood pressure problems in people with typical or atypical Parkinson's Disease who experience orthostatic hypotension. This study is led by Ecole Polytechnique Fédérale de Lausanne and focuses on improving hemodynamic stability in this population. All participants will receive the ARC-IM Investigational System, which includes implantation of a stimulation lead near the lower thoracic spinal cord and a neurostimulator implanted in the abdomen. The study observes participants over up to five years, monitoring the effects of the device on blood pressure and symptoms related to orthostatic hypotension. During the study, participants will undergo various tests such as a 10-minute orthostatic head-up tilt test, symptom questionnaires, balance and walking tests, and usability assessments of the ARC-IM System at multiple time points including 1 month, 6 months, and 1 year after therapy configuration. Researchers will closely track any serious device-related adverse effects from baseline throughout the study duration to assess safety and tolerability.
CONDITIONS
Brief Title
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Diagnosed with typical or atypical Parkinson's Disease, including Multiple System Atrophy, Pure Autonomic Failure, or Progressive Supranuclear Palsy
- Confirmed orthostatic hypotension verified by a verticalization test
- Have symptomatic orthostatic hypotension that significantly affects daily activities as determined by study clinicians
- Able to provide informed consent before any study procedures
- Stable medical, physical, and psychological conditions as assessed by investigators
- Able to understand and communicate in French or English
- Willing to comply with all study conditions and attend scheduled appointments
You will not qualify if you...
- Conditions that increase risks related to implantation surgery
- Unable to stop antiplatelet or anticoagulation medications around surgery
- History of heart attack or stroke within the past 6 months
- Unstable or significant medical conditions interfering with study or evaluation
- Major psychiatric or neurocognitive disorders as assessed by investigators
- Planned major changes in Parkinson's Disease treatment during the study phase
- Unable to follow study procedures
- Spinal abnormalities preventing surgery
- Need for frequent MRI scans
- Current pregnancy or breastfeeding
- Lack of effective contraception for women who can become pregnant
- Planning pregnancy during the study
- Inability or unwillingness to use the study system or devices effectively
- Participation in another interventional study that may affect results
- Investigator or related persons enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of a stimulation lead on the low thoracic spinal cord and a neurostimulator in the abdominal region as part of the ARC-IM Investigational System.
1 visit (surgical implantation)
Duration - Up to 5 years
Participants receive the ARC-IM Therapy through the implanted system to support hemodynamic management.
Visits at configuration, 6 months, and 1 year after therapy setup; additional assessments may occur as needed
Duration - Up to 5 years
Participants are monitored for safety and efficacy outcomes including symptom severity and device satisfaction up to 5 years after treatment.
Visits at 6 months and 1 year after therapy configuration for user feedback and usability assessments
Trial Site Locations
Total: 1 location
1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
G
Gregoire Courtine, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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