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

Ecole Polytechnique Fédérale de Lausanne

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: ARC-IM System implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06295614

SPARKL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Typical form of Parkinson's Disease with III-V 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,
• Must use safe contraception for women of childbearing capacity,
• Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits.
• Must provide and sign the study's Informed Consent prior to any study-related procedures.

Exclusion criteria

• 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,
• History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist,
• Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation),
• Diseases and conditions that would increase the morbidity and mortality of the implantation surgery,
• Spinal anatomical abnormalities precluding surgery,
• History of drug or alcohol abuse in the past 5 years,
• Life expectancy of less than 12 months,
• Pregnant or breast feeding,
• Intention to get pregnant during the course of the study,
• Indication requiring frequent Magnetic Resonance Imaging (MRI),
• Experimental treatment taken in the past 5 years,
• Participation in another interventional study,
• Enrolment of the investigator, his/her family members, employees, and other dependent persons.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

All participants

Experimental group

Description:

All participants enrolled in the study will receive the same intervention. The first year of the study consists of the following phases: enrolment, baseline assessments, surgical implantation of the ARC-IM stimulation device, configuration sessions for stimulation, in-clinic and at-home rehabilitation, and a home-use phase. It is followed by 3 years of safety follow-up. Assessments will be planned throughout the course of the study and at baseline, the end of the optimization phase, the end of the rehabilitation phase, and after 12 months post-surgery.

Treatment:

Device: ARC-IM System implantation