Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEcole Polytechnique Fédérale de Lausanne

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • ARC-IM System implantation

Treatment groups

6 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ecole Polytechnique Fédérale de Lausanne

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Sponsor institution