Epidural stimulation therapy for improving movement in Parkinson's disease
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
This study is testing a new spinal cord stimulation therapy to see if it can help people with advanced Parkinson's disease move better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT06295614 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the ARC-IM spinal cord stimulation therapy in individuals with Parkinson's disease who experience significant locomotor deficits. The therapy utilizes epidural electrical stimulation to enhance leg muscle recruitment, aiming to improve mobility and overall quality of life. The study will enroll six participants with advanced Parkinson's disease and will involve surgical implantation of the stimulation device, followed by rehabilitation phases and a three-year safety follow-up. The trial is conducted at the Lausanne University Hospital in Switzerland.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with typical Parkinson's disease and debilitating locomotor deficits despite optimal medical management.
Not a fit: Patients with atypical forms of Parkinson's disease or those whose gait problems are caused by factors unrelated to Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve mobility and quality of life for patients with Parkinson's disease.
How similar studies have performed: Previous studies, such as the STIMO-PARKINSON trial, have shown promising results with similar epidural electrical stimulation approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lausanne, Canton of Vaud
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jocelyne Bloch, MD — Centre hospitalier universitaire vaudois (CHUV)
- Study coordinator: Jocelyne Bloch, MD
- Email: jocelyne.bloch@chuv.ch
- Phone: +41 79 556 29 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.