Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •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.
排除标准
- •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.
研究组 & 干预措施
All participants
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.
干预措施: ARC-IM System implantation (Device)
结局指标
主要结局
Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system.
时间窗: From enrollment until end of safety follow-up phase (4 years)
Assess the safety of the ARC-IM Therapy at alleviating locomotor deficits in people with Parkinson's Disease.
次要结局
- 10-meter walk test(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- 6-minute walk test(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- Timed up and Go and its cognitive version(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- King's Parkinson's disease Pain Scale (KPPS)(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- Mini Balance Evaluation Systems Test (mini-BESTest)(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Monthly, from the start of the study until the end of the home-use phase (~12 months))
- Activities specific Balance Confidence Questionnaire (ABC-Q)(Monthly, from the start of the study until the end of the home-use phase (~12 months))
- Daily falls tracking(Weekly, from the start of the study until the end of the home-use phase (~12 months))
- Freezing of gait circuit(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- Muscle analysis(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV.(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- Home-use kinematic monitoring(Weekly, from the start of the study until the end of the home-use phase (~12 months))
- User Evaluation of Satisfaction with technology (QUEST 2.0)(Follow-Up assessments (~4 & 11 months post-surgery))
- Kinematic analysis(Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery))
- The Freezing of Gait Questionnaire (FOG-Q)(Monthly, from the start of the study until the end of the home-use phase (~12 months))
- Satisfaction questionnaire(Monthly, from the Short-Term assessments (~1 month post-surgery) until the end of the home-use phase (~12 months))
- System Usability Scale (SUS)(Follow-Up assessments (~4 & 11 months post-surgery))
研究者
Jocelyne Bloch
Prof.
Centre Hospitalier Universitaire Vaudois