protocolSection identificationModule nctId: NCT06295614, orgStudyIdInfo id: SPARKL, briefTitle: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease, acronym: SPARKL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ecole Polytechnique Fédérale de Lausanne, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-site, single-arm, non-blinded, non-randomized, interventional, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: ARC-IM System implantation, outcomesModule primaryOutcomes measure: Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system., secondaryOutcomes measure: 10-meter walk test, secondaryOutcomes measure: 6-minute walk test, secondaryOutcomes measure: Timed up and Go and its cognitive version, secondaryOutcomes measure: Freezing of gait circuit, secondaryOutcomes measure: Kinematic analysis, secondaryOutcomes measure: Muscle analysis, secondaryOutcomes measure: Mini Balance Evaluation Systems Test (mini-BESTest), secondaryOutcomes measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, secondaryOutcomes measure: King's Parkinson's disease Pain Scale (KPPS), secondaryOutcomes measure: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV., secondaryOutcomes measure: Parkinson's Disease Questionnaire-39 (PDQ-39), secondaryOutcomes measure: Activities specific Balance Confidence Questionnaire (ABC-Q), secondaryOutcomes measure: The Freezing of Gait Questionnaire (FOG-Q), secondaryOutcomes measure: Home-use kinematic monitoring, secondaryOutcomes measure: Daily falls tracking, secondaryOutcomes measure: Satisfaction questionnaire, secondaryOutcomes measure: User Evaluation of Satisfaction with technology (QUEST 2.0), secondaryOutcomes measure: System Usability Scale (SUS), otherOutcomes measure: Nerve conduction studies (NCS), otherOutcomes measure: Somato-sensory evoked potential (SSEP), otherOutcomes measure: Cortical signal recording, otherOutcomes measure: Kinematic analysis in different therapeutic conditions, otherOutcomes measure: Muscle analysis in different therapeutic conditions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire Vaudois (CHUV), status: RECRUITING, city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Jocelyne Dr Bloch, Prof. Dr., role: CONTACT, geoPoint lat: 46.516, lon: 6.63282, hasResults: False