[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100378840":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":68,"collaborators":70,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":27,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":27,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":27,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Florida","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Naive","ACTIVE_COMPARATOR","Participants receiving Long-term stimulation of the thalamus via dual leads for Essential Tremor",[13,14,15],"Device: Medtronic Summit Rechargable (RC)+S","Procedure: standard ET DBS","Procedure: ipsilateral VO",{"label":17,"type":10,"description":18,"interventionNames":19},"Refractory Participants","Patients with recurrent, debilitating intention tremor despite ongoing, optimized VIM DBS therapy",[13,20],"Procedure: ipsilateral thalamic (VIM+VO) DBS",[22,28,33,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Medtronic Summit Rechargable (RC)+S","Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO",[17,9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","ipsilateral thalamic (VIM+VO) DBS","Implantation of two new ipsilateral thalamic (VIM+VO) DBS",[17],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"standard ET DBS","Single Lead VIM",[9],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":27},"ipsilateral VO","second lead in the ipsilateral VO",[9],[42],{"name":43,"affiliation":5,"role":44},"Karim Oweiss, PhD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Cami Swartz","CONTACT","352-733-2429","cami.swartz@neurology.ufl.edu",{"name":43,"role":48,"phone":52,"phoneExt":27,"email":53},"352-294-1898","koweiss@ufl.edu",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":27},"RECRUITING","Gainesville","Florida","32611","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-82.32483,29.65163,{"lat":66,"lon":65},{"type":69,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[71,74],{"name":72,"class":73},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":75,"class":76},"Medtronic","INDUSTRY","100378840","dual-lead-thalamic-deep-brain-recording-dbr-dbs-interface-for-closed-loop-control-of-severe-essential-tremor-100378840",false,"NCT04212780","Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor","Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor","Inclusion Criteria:\n\n* Patient gives an informed consent.\n* Patient is over 21 years of age.\n* Patient is diagnosed with a postural-intention (essential) tremor for at least 3 years, meets diagnostic criteria for ET, has been evaluated and examined by a movement disorders fellowship trained neurologist, and is being treated with traditional VIM DBS therapy.\n* Patient has no evidence of non-ET central nervous system disease or injury and has had a significantly disabling, upper extremity tremor despite ongoing VIM DBS therapy for at least three (3) months prior to DBS revision surgery.\n* Patient has a postural or kinetic tremor severity score of at least 2 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (TRS) despite ongoing VIM DBS therapy.\n* Patient has a TRS score of 2 or above in any one of the items 16-23 from the Disability subsection of the TRS: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working and social activities despite ongoing VIM DBS therapy.\n* Patient's tremor is refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. Proof of this is not required for patients with a current device that is being removed and replaced with a new device. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.\n* Patient is available for appropriate follow-up times for the length of the study.\n\nExclusion Criteria:\n\n* Any previous neurosurgical intervention other than VIM DBS, including ablative brain lesions for tremor suppression.\n* Medication related movement disorders.\n* Any suspicion of Parkinson's disease, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.\n* Any behaviors consistent with alcohol or substance abuse as defined by the criteria outlined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).\n* Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.\n* Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions. Also excluded will be subjects with severe brain atrophy.\n* Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).\n* A history of seizures within the past year.\n* A dementia rating scale score (DRS) \\\u003C130 signifying significant cognitive dysfunction and a potential for inability to cooperate with tasks involved in the study.\n* Any attempt or intent of suicide during the previous six months.\n* Presence or history of psychosis.\n* Any person known to have abnormal coagulation or any medications which interfere with coagulation\n* Significant untreated or unstable mood disorders including depression. This will be determined by the Neuropsychological team during FastTrack and by the Neurologist\n* In addition, patients who are pregnant or plan to become pregnant will be excluded from this study.",true,"ALL","21 Years","99 Years",{"count":89,"type":90},10,"ESTIMATED","INTERVENTIONAL",[93],"NA","This is a feasibility study based on physician-initiated Investigational Device Exemption (IDE) including intraoperative experiments and chronic testing of implanted dual thalamic DBS lead systems. This study will inform protocols for optimal use of implanted next-gen DBS systems for primarily tremor control in refractory essential tremor.If the approach appears to be successful, the pilot data generated will be used to base a future pivotal trial for FDA approval for enhanced tremor control and adaptive DBS (aDBS) functionality of DBS systems.",[96],"Essential Tremor","2026-02-05",{"date":99,"type":100},"2026-02-10","ACTUAL",{"date":102,"type":100},"2019-12-24",{"date":104,"type":90},"2029-12-31",{"name":5,"class":6},1]