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.
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,
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,
Single group
ARC-IM System implantation
DeviceImplantation of a stimulation lead on the lumbar level of the spinal cord and implantation of a neurostimulator in the abdominal region.
Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system.
Assess the safety of the ARC-IM Therapy at alleviating locomotor deficits in people with Parkinson's Disease.
10-meter walk test
To assess gait speed. Measurement tool: time (s)
6-minute walk test
To assess endurance. Measurement tool: distance (m)
Timed up and Go and its cognitive version
To assess freezing of gait prevalence. Measurement tool: time (s)
Freezing of gait circuit
To assess freezing of gait prevalence. Measurement tool: time (s)
Nerve conduction studies (NCS)
To assess status of peripheral nervous system. Measurement tool: electrical activity in the nerve (mV)
Somato-sensory evoked potential (SSEP)
To assess the transmission of electrical activity from a touch stimulation. Measurement tool: electrical activity in the nerve (mV)
Cortical signal recording
To assess changes in brain activity patterns. Measurement tool: electrical activity in the brain (mV)
Kinematic analysis in different therapeutic conditions
Gait circuit to assess gait kinematic changes. Measurement tool: changes in position and orientation of the body through sensors (mm)
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
