Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
NCT06295614 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-07-11
Summary
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.
Conditions
- Parkinson Disease
Interventions
- DEVICE
-
ARC-IM System implantation
Implantation of a stimulation lead on the lumbar level of the spinal cord and implantation of a neurostimulator in the abdominal region.
Sponsors & Collaborators
-
Ecole Polytechnique Fédérale de Lausanne
lead OTHER
Principal Investigators
-
Jocelyne Bloch, MD · Centre hospitalier universitaire vaudois (CHUV)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-14
- Primary Completion
- 2029-04-01
- Completion
- 2029-04-01
Countries
- Switzerland
Study Locations
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