Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: ARC-IM System implantation
- Registration Number
- NCT06295614
- Lead Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All participants ARC-IM System implantation 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.
- Primary Outcome Measures
Name Time Method Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system. 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.
- Secondary Outcome Measures
Name Time Method 10-meter walk test Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) To assess gait speed. Measurement tool: time (s)
6-minute walk test Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) To assess endurance. Measurement tool: distance (m)
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) To assess freezing of gait prevalence. Measurement tool: time (s)
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) 7-item questionnaire to assess daily life performance. Measurement tool: total score 0 up to 168. Low score means a better outcome.
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) 4-item test to assess balance. Measurement tool: total score
Parkinson's Disease Questionnaire-39 (PDQ-39) Monthly, from the start of the study until the end of the home-use phase (~12 months) 39-item questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 100. Low score means a better outcome.
Activities specific Balance Confidence Questionnaire (ABC-Q) Monthly, from the start of the study until the end of the home-use phase (~12 months) 16-item questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 100. High score means a better outcome.
Daily falls tracking Weekly, from the start of the study until the end of the home-use phase (~12 months) To assess daily falls. Measurement tool: number of falls
Freezing of gait circuit Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) To assess freezing of gait prevalence. Measurement tool: time (s)
Muscle analysis Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) Gait circuit to assess muscle activity. Measurement tool: muscle activity through sensors (mV)
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) 19 item-test to assess the course of Parkinson's Disease. Measurement tool: total score from 0 up to 132. Low score means a better outcome.
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) 3-part questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 128. Low score means a better outcome.
Home-use kinematic monitoring Weekly, from the start of the study until the end of the home-use phase (~12 months) To assess gait pattern in ecological environment. Measurement tool: changes in position and orientation of the feet through sensors placed on shoes (mm)
User Evaluation of Satisfaction with technology (QUEST 2.0) Follow-Up assessments (~4 & 11 months post-surgery) 12-item questionnaire to assess usability of the therapy. Measurement tool: total score from 12 up to 60. Low score means a better outcome.
Kinematic analysis Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) Gait circuit to assess gait kinematic. Measurement tool: changes in position and orientation of the body through sensors (mm)
The Freezing of Gait Questionnaire (FOG-Q) Monthly, from the start of the study until the end of the home-use phase (~12 months) 6-item questionnaire to assess daily life performance. Measurement tool: total score 0 up to 24. High score means a better outcome.
Satisfaction questionnaire Monthly, from the Short-Term assessments (~1 month post-surgery) until the end of the home-use phase (~12 months) 16-item questionnaire to collect feedback from the therapy. Measurement tool: total score from 0 up to 100.
System Usability Scale (SUS) Follow-Up assessments (~4 & 11 months post-surgery) Questionnaire to assess usability of the therapy. Measurement tool: total score from 0 to 100. High score means a better outcome.
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Vaud, Switzerland