protocolSection identificationModule nctId: NCT06325852, orgStudyIdInfo id: 22-5772, briefTitle: Directional Bilateral Thalamic Patterned Stimulation (Chronos), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Alfonso Fasano, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits., conditionsModule conditions: Essential Tremor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: DBS programing, outcomesModule primaryOutcomes measure: Tremor Rating Scale (Part A-B), primaryOutcomes measure: Tremor analysis, primaryOutcomes measure: Tremor Rating Scale (A-C), primaryOutcomes measure: Tremor analysis (meter per second squared), primaryOutcomes measure: Gait speed (meter per second), primaryOutcomes measure: Base of support (meter), primaryOutcomes measure: Step length (meter), primaryOutcomes measure: Stride length (meter), primaryOutcomes measure: Single stance time and double stance time (seconds), primaryOutcomes measure: Tandem gait, primaryOutcomes measure: Posturography (newtons), primaryOutcomes measure: Quality of life in Essential Tremor Questionnaire (QUEST), primaryOutcomes measure: Speech analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Movement Disorders Centre - Toronto Western Hospital, city: Toronto, state: Ontario, zip: M5T 2S8, country: Canada, contacts name: Alfonso Fasano, MD, PhD, role: CONTACT, phone: (416) 603-5800, phoneExt: 5961, email: alfonso.fasano@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False