[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616709":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":63,"collaborators":65,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":10,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 (Pilot group)",null,"Description: First 3 participants with primary dystonia undergoing DBS. Used to optimize LFP sensing workflow and confirm the feasibility of data collection.\n\nPopulation: Adults (≥18 years) with primary dystonia scheduled for GPi DBS. Purpose: Workflow development and initial LFP data collection.",[13],"Device: Deep Brain Stimulation System",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 (Main observational group)","Description: 8-10 participants with primary dystonia undergoing DBS and programmed using traditional clinical methods. LFP recordings are collected at each visit for correlation analysis.\n\nPopulation: Adults with primary dystonia (including idiopathic cervical dystonia and generalized dystonia).\n\nPurpose: Assess the relationship between LFP profiles and optimal stimulation sites determined by standard programming.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3 (Exploratory programming group)","Description: 10-15 participants with primary dystonia who may receive programming guided by LFP analysis if interim results support feasibility.\n\nPopulation: Adults with primary dystonia undergoing DBS. Purpose: Explore whether LFP-guided programming improves clinical outcomes compared to traditional methods.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Deep Brain Stimulation System","The Medtronic Percept™ DBS system will be used as part of standard clinical care for dystonia. The study will utilize the device's sensing capabilities (BrainSense™) to record local field potentials for research purposes.",[9,15,19],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"David Ledingham, MA, MBBS","CONTACT","+441912826161","david.ledingham1@nhs.net",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Clinical Ageing Research Unit,","RECRUITING","Newcastle upon Tyne","Tyne & Wear","NE4 6BE","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-1.61396,54.97328,{"lat":47,"lon":46},[50,52,54,57,59,61],{"name":30,"role":31,"phone":51,"phoneExt":10,"email":33},"+441912336161",{"name":30,"role":53,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Nicola Pavese, MD, PhD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":10,"phoneExt":10,"email":10},"Mark Baker, MA, MBBChir",{"name":60,"role":56,"phone":10,"phoneExt":10,"email":10},"Mohammed Hussain, BSc, MBBS",{"name":62,"role":56,"phone":10,"phoneExt":10,"email":10},"Claire Nicholson, BSc, BA, MB ChB",{"type":64,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[66,69],{"name":67,"class":68},"Medtronic","INDUSTRY",{"name":70,"class":71},"Dystonia Europe","UNKNOWN","100616709","local-field-potentials-in-dystonia-100616709",false,"NCT07309133","Local Field Potentials in Dystonia","Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials","LFP-DYT","Inclusion Criteria:\n\n* Age 18 years or older at screening.\n* Clear clinical diagnosis of primary dystonia (idiopathic or genetic forms).\n* Candidate for GPi DBS surgery for dystonia treatment.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Significant neurological or psychiatric disorder (including dementia) that would interfere with outcome evaluation.\n* Participation in a therapeutic research trial within the last year.\n* Diagnosis of functional (psychogenic) dystonia.","ALL","18 Years",{"count":83,"type":84},25,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to learn whether local field potential (LFP) signals recorded from the globus pallidus interna (GPi) using the Medtronic Percept™ deep brain stimulation (DBS) device can help optimize DBS programming for people with dystonia. The study will also explore whether LFP patterns can serve as a biomarker of disease activity and predict treatment response.\n\nThe main questions it aims to answer are:\n\nDo LFP peaks in the alpha-theta range reliably correlate with dystonia severity and clinical characteristics? Can LFP-based programming achieve similar or better clinical outcomes compared to traditional programming methods? How do LFP profiles change with stimulation and other treatments such as botulinum toxin or oral medications?\n\nResearchers will compare two programming approaches:\n\nTraditional programming based on clinical assessment and imaging. LFP-guided programming based on the site and characteristics of LFP peaks\n\nParticipants will:\n\nUndergo DBS surgery for dystonia as part of standard clinical care. Attend regular follow-up visits for DBS programming and outcome assessments. Complete clinical rating scales for dystonia severity, quality of life, cognition, and mood.\n\nTake part in neurophysiological assessments, including surface EMG, EEG, and reaction time tasks.\n\nHave LFP recordings collected using the Medtronic Percept™ device during clinic visits and, where possible, at home using device sensing features.\n\nThis study will help determine whether LFP analysis can shorten the time to optimal DBS settings and improve outcomes for people with dystonia.",[88,89,90],"Dystonia","Dystonia, Focal","Dystonia, Primary",[92,93,94,95,96,97],"Deep Brain Stimulation","DBS","Globus Pallidus Interna","Local Field Potentials","Neurostimulation","Neurophysiology","2025-12-15",{"date":100,"type":101},"2025-12-30","ACTUAL",{"date":103,"type":101},"2025-09-04",{"date":105,"type":84},"2028-12",{"name":5,"class":6},1]