RecruitingNot ApplicableNCT06295614

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


Sponsor

Ecole Polytechnique Fédérale de Lausanne

Enrollment

6 participants

Start Date

Feb 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the ARC-IM therapy — an implanted spinal cord stimulation device that delivers targeted electrical pulses to improve walking — in people with Parkinson's disease who have significant gait problems such as freezing of gait (suddenly being unable to move the feet) or postural instability (balance problems), despite optimal medication. **You may be eligible if...** - You have typical Parkinson's disease (Hoehn-Yahr stage II–IV) on standard therapy - You have debilitating walking problems (freezing of gait or postural instability) that are not well controlled by medication - You are 18 or older - You can communicate with the study team in French or English **You may NOT be eligible if...** - You have an atypical form of parkinsonism (such as Multiple System Atrophy or Progressive Supranuclear Palsy) - You have significant dementia or psychiatric conditions that would prevent participation - You have a pacemaker, cochlear implant, or other implanted device that could interfere with stimulation - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEARC-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.


Locations(1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

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NCT06295614


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