Actively Recruiting
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-07-11
6
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease.
CONDITIONS
Official Title
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Typical form of Parkinson's Disease with II-IV Hoehn-Yahr stage with standard therapy
- Debilitating locomotor deficits including gait impairments of postural instability and/or freezing of gait despite optimal medical management
- 18 years of age or older
- Able to understand and interact with the study team in French or English
- Use of safe contraception for women of childbearing capacity
- Agreement to comply with all study conditions and attend all training and visits
- Signed informed consent before any study procedures
You will not qualify if you...
- Atypical forms of Parkinson's Disease such as Multiple System Atrophy or Progressive Supranuclear Palsy
- Secondary causes of gait problems unrelated to Parkinson's Disease
- Inability to follow study procedures
- Unstable or significant medical condition interfering with study or evaluations
- History of major psychiatric or neurocognitive disorders
- Planned major change in Parkinson's treatment during the main study phase
- Conditions increasing risk from implantation surgery
- Spinal abnormalities preventing surgery
- Drug or alcohol abuse in past 5 years
- Life expectancy less than 12 months
- Pregnant, breastfeeding, or intending pregnancy during study
- Need for frequent Magnetic Resonance Imaging (MRI)
- Experimental treatment in past 5 years
- Participation in another interventional study
- Investigator and related persons' enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
J
Jocelyne Bloch, MD
CONTACT
E
Eduardo Martin Moraud, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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