[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dystonic-cerebral-palsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dystonic-cerebral-palsy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,70],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100525510","cerebellar-deep-brain-stimulation-for-movement-disorders-in-cerebral-palsy-in-children-and-young-adults-100525510",false,"NCT06122675","Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults","Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults With Cerebral Palsy","Inclusion Criteria:\n\n* Diagnosis of DCP (dystonic and\u002For choreoathetotic cerebral palsy) with or without comorbid spasticity, with a clear history of hypoxic ischemic brain injury preceding motor symptoms made by a pediatric neurologist, with supporting MRI findings.\n* Age 7-25 at the time of surgery.\n* Gross Motor Function Classification System (GMFCS) Levels II-V.\n* History of appropriate therapy with oral medications with inadequate relief as determined by a movement disorders or pediatric neurologist. Prior history of selective dorsal rhizotomy is allowed.\n* Patient and family have requested surgical intervention with DBS for their movement disorder.\n* No gross cerebellar abnormalities observed and reported on structural MRI.\n* Written informed consent and written\u002Fverbal assent for those younger than 18 years of age.\n* Ability to comply with study follow-up visits for brain recordings, neuroimaging and testing of sham and effective stimulation and clinical assessments.\n\nExclusion Criteria:\n\n* Coagulopathy, uncontrolled epilepsy, severe cardiopulmonary or gastrointestinal conditions, or other medical conditions considered to place the patient at elevated risk for surgical complications.\n* Pregnancy: all women of child-bearing potential will be required to have a negative urine pregnancy test prior to undergoing their surgical procedure.\n* Exclusion of genetic mimics of cerebral palsy: exclusion of conditions that manifest with a clinical syndrome similar to CP, in the absence of documented risk factors or neuroimaging findings consistent with a history of brain injury or congenital cerebral malformation. Work up may include comparative genomic hybridization (CGH) microarray and multi-gene panel and\u002For whole genome or whole exome sequencing.)\n* Severe fixed contractions and skeletal deformities that would preclude determination of improvement.\n* Traumatic brain injury (i.e., non-accidental trauma) or history of infectious or autoimmune encephalitis.\n* Requirement of diathermy, electroconvulsive therapy or transcranial magnetic stimulation.","ALL","7 Years","25 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to test the safety of placing Deep Brain Stimulators (DBS) in a part of the brain called the cerebellum and using electrical stimulation of that part of the brain to treat movement symptoms related to cerebral palsy. Ten children and young adults with dyskinetic cerebral palsy will be implanted with a Medtronic Percept Primary Cell Neurostimulator. We will pilot videotaped automated movement recognition techniques and formal gait analysis, as well as collect and characterize each subject's physiological and neuroimaging markers that may predict hyperkinetic pathological states and their response to therapeutic DBS.",[27,28],"Dyskinetic Cerebral Palsy","Dystonic Cerebral Palsy","RECRUITING","2026-06-03",{"date":32,"type":33},"2026-06-05","ACTUAL",{"date":35,"type":33},"2024-03-26",{"date":37,"type":21},"2029-03-31",{"name":39,"class":40},"University of California, San Francisco","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100562700","intrathecal-baclofen-and-pediatric-dystonia-100562700","NCT06606574","Intrathecal Baclofen and Pediatric Dystonia","PREDICT-ITB: Predicting Response in Children With Dystonic Cerebral Palsy to Intrathecal Baclofen","PREDICT-ITB","Inclusion Criteria:\n\n* Child must be large enough to have an ITB pump implanted (typically \\~18 kg\u002F4 years old)\n* They have a diagnosis of CP\n* Presence of dystonia verified with a documented Hypertonia Assessment Tool (HAT) and they must have a Barry-Albright Dystonia Scale (BADS) score \\&gt;15\n* They have been identified by a physician for ITB treatment for tone management and the family\u002Fchild have agreed to proceed with implantation; note: an ITB trial dose is not necessary to qualify\n* Child and family are willing to participate in full schedule of formal assessments, spanning pre-implantation, every 2 weeks until ideal intrathecal baclofen pump dosing is reached, and follow-up assessments\n\nExclusion Criteria:\n\n* Emergent need for ITB such as status dystonicus or paroxysmal sympathetic hyperactivity\n* Botulinum injections within 3 months or phenol injections within 6 months of enrollment\n* Foster care placement or incarceration","17 Years",{"count":52,"type":21},65,[24],"The goal of this clinical trial is to better understand the effects of intrathecal baclofen (ITB) on children with dystonic cerebral palsy (CP).\n\nThe main questions this study aims to answer are:\n\n(1) Determine if ITB reduces dystonia while identifying other potential benefits, (2) Identify the characteristics of children with the best response to ITB (3) Develop a holistically representative composite outcome measure for dystonic CP.\n\nThis study will evaluate patient improvement by using a standardized titration, or medication management, protocol to gradually increase the childs ITB dosages over a 12-month period until they achieve maximum benefit with minimal to no side effects. This titration protocol mimics what is currently done through routine care but with more precision. This study will also directly measure the global effects of ITB, taking into account spasticity, known dystonia triggers (e.g. pain), and patterns of CNS injury that cause dystonia.\n\nParticipants will:\n\n1. Complete a total of 4 additional clinic visits outside usual care. These appointments will be with physical and occupational therapists as well as the study PI to complete evaluations for dystonia, spasticity, and function.\n2. Complete several questionnaires at these visits. The total duration of the study for an individual child will be 12 months.",[28],[57,58,59,60],"Intrathecal baclofen","Spasticity","Dystonia","Cerebral Palsy","2025-07-27",{"date":63,"type":33},"2025-07-30",{"date":65,"type":33},"2024-11-01",{"date":67,"type":21},"2029-08-31",{"name":69,"class":40},"Baylor College of Medicine",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":16,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100486314","enhancing-sensorimotor-processing-in-children-with-dystonia-100486314","NCT05612464","Enhancing Sensorimotor Processing in Children With Dystonia","Enhancing Cortical Sensorimotor Processing in Children\u002FYoung People With Dystonia and Dystonic Cerebral Palsy - An Observational Study to Evaluate Whether Neurofeedback Can Enhance Modulation of the mu Brain Rhythm in Children and Young People With Dystonia\u002FDystonic Cerebral Palsy","Key inclusion criteria\n\nControl Group:\n\n* Age 5 -25 years\n* No known disorder of movement\n* Able to understand and participate in study.\n\nPrimary dystonia group (isolated genetic or idiopathic):\n\n* Age 5-25 years\n* Clinical dystonia - as confirmed on clinical assessment by consultant paediatric neurologist.\n* Genetic or idiopathic aetiology.\n* No other neurological abnormality.\n* Normal cranial magnetic resonance imaging (MRI).\n* Able to understand and participate in study.\n\nDystonic Cerebral Palsy Group:\n\n* Age 5-25 years\n* Clinical dystonia\u002Fdyskinesia - as confirmed on clinical assessment by consultant paediatric neurologist.\n* Documented history of perinatal hypoxic-ischaemic encephalopathy (HIE), prematurity \\\u003C35 weeks or kernicterus.\n* Predominant dystonia\u002Fdyskinesia \u002F Minimal spasticity\n* MRI findings in keeping with acute perinatal HIE, prematurity or kernicterus (including classical pattern of damage to thalami, basal ganglia and peri-rolandic cortex, periventricular leukomalacia or ischaemic parenchymal injury).\n* Able to understand and participate in study.\n\nKey exclusion criteria\n\nControl Group:\n\n* Age \\\u003C5 or \\>25 years\n* Any known disorder of movement.\n\nPrimary dystonia group (isolated genetic or idiopathic):\n\n* Age \\\u003C 5 or \\>25 years\n* Presence of other neurological abnormality in addition to dystonia.\n* Abnormal cranial MRI.\n\nDystonic Cerebral Palsy Group:\n\n* Age \\\u003C 5 or \\>25 years\n* No clear history of perinatal HIE, prematurity or kernicterus.\n* Predominant spasticity.\n* MRI scan not compatible with perinatal HIE, prematurity or kernicterus",true,"5 Years",{"count":80,"type":21},90,"OBSERVATIONAL","Dystonia is a severely disabling movement disorder with no cure, in which people suffer painful muscle spasms causing twisting movements and abnormal postures. There are many causes, including genetic conditions and brain injury. The most common cause in childhood is dystonic cerebral palsy (CP) which often affects the whole body.\n\nThe underlying mechanisms are unknown, but there is growing evidence to implicate abnormal brain processing by the brain of incoming \"sensory\" information (e.g., signals to the brain from our senses of touch and body position): the distorted perception of these signals disrupts the way the brain produces instructions for planning and performing movements.\n\nThe investigator's previous studies have shown that the way the brain processes sensory information related to movement is abnormal in children with dystonia and dystonic CP, by using methods that record the EEG (electroencephalogram - brain wave signals) and\u002For EMG (electromyogram - electrical signal from muscles). A specific brain rhythm (called mu) typically shows well-defined changes in response to movement, and reflects processing of sensory information. The investigator's work shows these rhythm changes are abnormal in children with dystonia\u002Fdystonic CP.\n\nThis study will explore if these findings can improve treatment. In particular the study team will investigate whether children and young people with dystonia\u002Fdystonic CP can enhance these mu rhythm responses during a movement task by using feedback of their brain rhythms displayed as a cartoon\u002Fgame on a computer. The investigators will also assess whether enhanced mu activity is associated with improved movement control. This would open future possibilities to use such devices for therapy\u002Frehabilitation.\n\nChildren and young people with dystonia\u002Fdystonic CP aged 5-25 years will be recruited, along with age-matched controls. Studies will last 2-3 hours with time for breaks and will be conducted at Evelina London Children's Hospital and Barts Health Trust, with the option for home visits if preferable for families.",[59,28,84,85,86],"Dystonia, Secondary","Dystonia, Primary","Dystonia; Idiopathic","NOT_YET_RECRUITING","2022-11-09",{"date":90,"type":33},"2022-11-10",{"date":92,"type":21},"2023-02-01",{"date":94,"type":21},"2028-02-01",{"name":96,"class":40},"King's College London"]