[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538805":3},{"organization":4,"outcomesModule":7,"designInfo":102,"detailedDescription":110,"studyPopulation":107,"armGroups":111,"interventions":118,"overallOfficials":124,"centralContacts":129,"locations":138,"responsibleParty":156,"collaborators":107,"id":160,"slug":107,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":161,"sex":166,"minAge":167,"maxAge":107,"enrollmentInfo":168,"targetDuration":107,"studyType":171,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":141,"whyStopped":107,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Ecole Polytechnique Fédérale de Lausanne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":83},[9],{"measure":10,"description":11,"timeFrame":12},"Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system.","Assess the safety of the ARC-IM Therapy at alleviating locomotor deficits in people with Parkinson's Disease.","From enrollment until end of safety follow-up phase (4 years)",[14,18,21,24,26,29,32,35,38,41,44,48,51,54,58,61,65,69,72,76,80],{"measure":15,"description":16,"timeFrame":17},"10-meter walk test","To assess gait speed. Measurement tool: time (s)","Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)",{"measure":19,"description":20,"timeFrame":17},"6-minute walk test","To assess endurance. Measurement tool: distance (m)",{"measure":22,"description":23,"timeFrame":17},"Timed up and Go and its cognitive version","To assess freezing of gait prevalence. Measurement tool: time (s)",{"measure":25,"description":23,"timeFrame":17},"Freezing of gait circuit",{"measure":27,"description":28,"timeFrame":17},"Kinematic analysis","Gait circuit to assess gait kinematic. Measurement tool: changes in position and orientation of the body through sensors (mm)",{"measure":30,"description":31,"timeFrame":17},"Muscle analysis","Gait circuit to assess muscle activity. Measurement tool: muscle activity through sensors (mV)",{"measure":33,"description":34,"timeFrame":17},"Mini Balance Evaluation Systems Test (mini-BESTest)","4-item test to assess balance. Measurement tool: total score",{"measure":36,"description":37,"timeFrame":17},"Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III","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.",{"measure":39,"description":40,"timeFrame":17},"King's Parkinson's disease Pain Scale (KPPS)","7-item questionnaire to assess daily life performance. Measurement tool: total score 0 up to 168. Low score means a better outcome.",{"measure":42,"description":43,"timeFrame":17},"The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV.","3-part questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 128. Low score means a better outcome.",{"measure":45,"description":46,"timeFrame":47},"Parkinson's Disease Questionnaire-39 (PDQ-39)","39-item questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 100. Low score means a better outcome.","Monthly, from the start of the study until the end of the home-use phase (~12 months)",{"measure":49,"description":50,"timeFrame":47},"Activities specific Balance Confidence Questionnaire (ABC-Q)","16-item questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 100. High score means a better outcome.",{"measure":52,"description":53,"timeFrame":47},"The Freezing of Gait Questionnaire (FOG-Q)","6-item questionnaire to assess daily life performance. Measurement tool: total score 0 up to 24. High score means a better outcome.",{"measure":55,"description":56,"timeFrame":57},"Home-use kinematic monitoring","To assess gait pattern in ecological environment. Measurement tool: changes in position and orientation of the feet through sensors placed on shoes (mm)","Weekly, from the start of the study until the end of the home-use phase (~12 months)",{"measure":59,"description":60,"timeFrame":57},"Daily falls tracking","To assess daily falls. Measurement tool: number of falls",{"measure":62,"description":63,"timeFrame":64},"Satisfaction questionnaire","16-item questionnaire to collect feedback from the therapy. Measurement tool: total score from 0 up to 100.","Monthly, from the Short-Term assessments (~1 month post-surgery) until the end of the home-use phase (~12 months)",{"measure":66,"description":67,"timeFrame":68},"User Evaluation of Satisfaction with technology (QUEST 2.0)","12-item questionnaire to assess usability of the therapy. Measurement tool: total score from 12 up to 60. Low score means a better outcome.","Follow-Up assessments (~4 & 11 months post-surgery)",{"measure":70,"description":71,"timeFrame":68},"System Usability Scale (SUS)","Questionnaire to assess usability of the therapy. Measurement tool: total score from 0 to 100. High score means a better outcome.",{"measure":73,"description":74,"timeFrame":75},"Montreal Cognitive assessment (MoCA)","30-item test to assess global cognitive function across multiple domains including memory, attention, language, and executive function. Measurement tool: total score from 0 up to 30. High score means a better outcome.","Baseline (before surgery), Follow-Up assessments (~4 & 11 months post-surgery) and safety follow-up visits.",{"measure":77,"description":78,"timeFrame":79},"Patient Global Impression of Change (PGI-C)","7-point single-item scale assessing the patient's self-reported overall change since the start of treatment. Measurement tool: score from 1 to 7. Low score means a better outcome.","Short-Term assessments (~1 month post-surgery), Follow-Up assessments (~4 & 11 months post-surgery), and safety follow-up visits.",{"measure":81,"description":82,"timeFrame":79},"Semi-structured interview","Investigator-conducted interview assessing the participant's subjective well-being and the general effect of the therapy on daily life. Measurement tool: qualitative data.",[84,88,92,96,99],{"measure":85,"description":86,"timeFrame":87},"Nerve conduction studies (NCS)","To assess status of peripheral nervous system. Measurement tool: electrical activity in the nerve (mV)","Baseline assessments",{"measure":89,"description":90,"timeFrame":91},"Somato-sensory evoked potential (SSEP)","To assess the transmission of electrical activity from a touch stimulation. Measurement tool: electrical activity in the nerve (mV)","Short-term assessments (~1 month post-surgery)",{"measure":93,"description":94,"timeFrame":95},"Cortical signal recording","To assess changes in brain activity patterns. Measurement tool: electrical activity in the brain (mV)","After surgery, until 18 weeks post-surgery",{"measure":97,"description":98,"timeFrame":95},"Kinematic analysis in different therapeutic conditions","Gait circuit to assess gait kinematic changes. Measurement tool: changes in position and orientation of the body through sensors (mm)",{"measure":100,"description":101,"timeFrame":95},"Muscle analysis in different therapeutic conditions","Gait circuit to assess muscle activity change. Measurement tool: muscle activity through sensors (mV)",{"allocation":103,"interventionModel":104,"interventionModelDescription":105,"primaryPurpose":106,"observationalModel":107,"timePerspective":107,"maskingInfo":108},"NA","SINGLE_GROUP","Single-site, single-arm, non-blinded, non-randomized, interventional","TREATMENT",null,{"masking":109,"maskingDescription":107,"whoMasked":107},"NONE","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.\n\nBuilding 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.\n\nThis 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.\n\nThroughout 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.",[112],{"label":113,"type":114,"description":115,"interventionNames":116},"All participants","EXPERIMENTAL","All participants enrolled in the study will receive the same intervention.\n\nThe 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.\n\nAssessments 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.",[117],"Device: ARC-IM System implantation",[119],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":107},"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.",[113],[125],{"name":126,"affiliation":127,"role":128},"Jocelyne Bloch, MD","Centre hospitalier universitaire vaudois (CHUV)","PRINCIPAL_INVESTIGATOR",[130,134],{"name":126,"role":131,"phone":132,"phoneExt":107,"email":133},"CONTACT","+41 79 556 29 51","jocelyne.bloch@chuv.ch",{"name":135,"role":131,"phone":136,"phoneExt":107,"email":137},"Eduardo Martin Moraud, Prof","+41 21 31 42 455","Eduardo.Martin-Moraud@chuv.ch",[139],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"Centre Hospitalier Universitaire Vaudois (CHUV)","RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":148,"coordinates":149},"Point",[150,151],6.63282,46.516,{"lat":151,"lon":150},[154],{"name":155,"role":131,"phone":107,"phoneExt":107,"email":107},"Jocelyne Dr Bloch, Prof. Dr.",{"type":128,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":159,"oldNameTitle":107,"oldOrganization":107},"Jocelyne Bloch","Prof.","Centre Hospitalier Universitaire Vaudois","100538805",false,"NCT06295614","Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease","SPARKL","Inclusion Criteria:\n\n* Typical form of Parkinson's Disease with II-IV Hoehn-Yahr stage with standard therapy,\n* Suffering from debilitating locomotor deficits, including gait impairments of either postural instability and\u002For freezing of gait, despite optimal medical management,\n* 18 years of age or older,\n* Able to understand and interact with the study team in French or English,\n* Must use safe contraception for women of childbearing capacity,\n* Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits.\n* Must provide and sign the study's Informed Consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Atypical forms of Parkinson's Disease (such as Multiple System Atrophy or Progressive Supranuclear Palsy),\n* Secondary causes of gait problems independent of Parkinson's Disease,\n* Inability to follow study procedures,\n* 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,\n* History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist,\n* Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation),\n* Diseases and conditions that would increase the morbidity and mortality of the implantation surgery,\n* Spinal anatomical abnormalities precluding surgery,\n* History of drug or alcohol abuse in the past 5 years,\n* Life expectancy of less than 12 months,\n* Pregnant or breast feeding,\n* Intention to get pregnant during the course of the study,\n* Indication requiring frequent Magnetic Resonance Imaging (MRI),\n* Experimental treatment taken in the past 5 years,\n* Participation in another interventional study,\n* Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons.","ALL","18 Years",{"count":169,"type":170},6,"ESTIMATED","INTERVENTIONAL",[103],"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.",[175],"Parkinson Disease",[175,177,178],"Spinal Cord Stimulation","Epidural Spinal Stimulation","2026-06-03",{"date":181,"type":182},"2026-06-04","ACTUAL",{"date":184,"type":182},"2024-02-14",{"date":186,"type":170},"2029-04-01",{"name":5,"class":6},1]