NCT06295614Recruiting
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 20 Feb 2024
- Start date
- 14 Feb 2024
- Primary completion date
- 1 Apr 2029
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Diseases
- Parkinson disease
- NCT number
- NCT06295614
What you commit to
- Study type: Interventional
- Planned participants: 6
- From 14 Feb 2024 to the primary completion date, 1 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Spinal anatomical abnormalities precluding surgery,
Other illness
- 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,
- 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,
- Diseases and conditions that would increase the morbidity and mortality of the implantation surgery,
- History of drug or alcohol abuse in the past 5 years,
Other
- Inability to follow study procedures,
- Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation),
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.