Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Recruiting · NCT06295614 · Interventional (participants receive a specific treatment) · Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
View the official record on ClinicalTrials.gov →Interventions studied
ARC-IM System implantation
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Typical form of Parkinson's Disease with II-IV Hoehn-Yahr stage with standard therapy,
- Suffering from debilitating locomotor deficits, including gait impairments of either 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,
- Must use safe contraception for women of childbearing capacity,
- Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits.
- Must provide and sign the study's Informed Consent prior to any study-related procedures.
Exclusion criteria
- Atypical forms of Parkinson's Disease (such as Multiple System Atrophy or Progressive Supranuclear Palsy),
- Secondary causes of gait problems independent of Parkinson's Disease,
- Inability to follow study procedures,
- Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator,
- History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist,
- Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation),
- Diseases and conditions that would increase the morbidity and mortality of the implantation surgery,
- Spinal anatomical abnormalities precluding surgery,
- History of drug or alcohol abuse in the past 5 years,
- Life expectancy of less than 12 months,
- Pregnant or breast feeding,
- Intention to get pregnant during the course of the study,
- Indication requiring frequent Magnetic Resonance Imaging (MRI),
- Experimental treatment taken in the past 5 years,
- Participation in another interventional study,
- Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Where it is running
1 location listed.
- Centre Hospitalier Universitaire Vaudois (CHUV) - Lausanne, Canton of Vaud, Switzerland