[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"secondary-dystonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:secondary-dystonia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100518873","focused-ultrasound-pallidotomy-for-dyskinetic-cerebral-palsy-in-pediatric-and-young-adult-subjects-100518873",false,"NCT06036199","Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects","Safety and Impact on Quality of Life of Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects","Inclusion Criteria:\n\n* The treating physician has chosen GPi-DBS or pallidotomy for the treatment of the secondary dystonia caused by cerebral palsy in this patient\n* Patient and\u002For legal representative, if the patient is underaged or not capable to give consent himself, have chosen pallidotomy as treatment\n* The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required\n* Age at enrolment 8-22 years\n* Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury\n* Anti-dystonic pharmacotherapy insufficient\n* Stable anti-dystonic medication over the last 30 days\n* Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible)\n* No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention\n* Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study\n* Informed consent to take part in the study from patient and\u002For legal representative if the patient is underaged or not capable to give consent himself\n* Patient and\u002For legal representative if the patient is underaged or not capable to give consent himself, understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed\n\nExclusion Criteria:\n\n* Patients with known primary (e.g. DYT1) or idiopathic dystonia\n* Severe axial hypotonia with total loss of head control (e.g. absence of control at \"upper thoracic level\" in the SATCo score) (medication effect excluded)\n* Fixed hemi-dystonia\n* Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale \\>3)\n* Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention\n* Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)\n* Condition likely to require use of MRI in the future\n* Any intracranial abnormality or medical condition that would contraindicate DBS surgery\n* Any findings in neuropsychological screening assessments that would contraindicate DBS surgery\n* Any current drug and \u002F or alcohol abuse\n* Any history of frequent grand-mal seizures without response to anticonvulsive treatment\n* Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device.\n* The presence of DBS leads due the risks of these ferromagnetic devices in the MRI environment.\n* A history of neurostimulation intolerance in any area of the body.\n* Currently on any anticoagulant medications that cannot be discontinued during perioperative period.\n* Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \\\u003C24 months.\n* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator.\n* A female that is breastfeeding or of childbearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all forms of hormonal contraception (\"antibaby-pill\", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent.\n* Subjects who have contraindications to anesthesia, in the judgment of the attending anesthesiologist\n* Subjects who are unwilling or unable to undergo general anesthesia\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.\n* Minimum head circumference \\\u003C 49cm\n* Skull Density Ratio (SDR) \\\u003C0.40.","ALL","8 Years","22 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of the proposed study is to evaluate the safety of ExAblate Transcranial MRgFUS as a tool for creating bilateral or unilateral lesions in the globus pallidus (GPi) in patients with treatment-refractory secondary dystonia due to dyskinetic cerebral palsy",[27,28],"Cerebral Palsy, Dyskinetic","Secondary Dystonia",[30,31],"High intensity focused ultrasound (HIFU)","Pallidotomy","RECRUITING","2026-06-09",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":38,"type":36},"2024-01-26",{"date":40,"type":21},"2028-08",{"name":42,"class":43},"Children's National Research Institute","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100368019","abbott-dbs-post-market-study-of-outcomes-for-indications-over-time-100368019","NCT04071847","Abbott DBS Post-Market Study of Outcomes for Indications Over Time","ADROIT","Inclusion Criteria:\n\n1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.\n2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.\n\nExclusion Criteria:\n\n1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.\n2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.\n3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.\n4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.",{"count":53,"type":21},1000,"OBSERVATIONAL","The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.",[57,58,59,60,61,62,28],"Movement Disorders","Parkinson Disease","Essential Tremor","Tremor","Dystonia","Primary Dystonia","2026-01-07",{"date":65,"type":36},"2026-01-08",{"date":67,"type":36},"2019-11-26",{"date":69,"type":21},"2030-09",{"name":71,"class":72},"Abbott Medical Devices","INDUSTRY",48]