NCT06295614

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Ecole Polytechnique Fédérale de Lausanne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The progression of Parkinson's Disease (PD) is often marked by the development of severe locomotor deficits, including gait impairments, which significantly affect patients' independence and are not effectively addressed by current treatments. The STIMO-PARKINSON (NCT04956770) clinical trial has shown promising results with epidural electrical stimulation (EES) in significantly reducing these locomotor deficits in Parkinson's Disease patients. Building on these findings, the SPARKL clinical study aims to further this research. The SPARKL study aims to enroll six individuals with advanced Parkinson's Disease to assess the safety and efficacy of the novel ARC-IM Therapy. This new therapy has been designed to overcome previous technological limitations and facilitate its home-use. This study will take place at the Lausanne University Hospital (CHUV, Switzerland). The total duration of the study is 4 years per participant. The study intervention consists of several phases preceded by pre-screening. The first year involves an intensive participation, consisting of the following phases: enrolment and baseline, surgical implantation of the stimulation device, a main study phase that includes stimulation configuration sessions and both in-clinic and at-home rehabilitation, and finally the home-use phase. This will be succeeded by 3 years of safety follow-up, during which the participant can use the stimulation device in their daily life, subject to investigator approval. Throughout the study, the investigators will conduct assessments at various stages of each participant's journey in the study. These assessments will be used to assess the preliminary safety and efficacy of the ARC-IM therapy at alleviating locomotor deficits.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-14
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-03-06
• Last updated: 2025-07-11

Locations

1 site across 1 country: Switzerland