Epidural stimulation therapy for improving movement in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.