[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657552":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":40,"overallOfficials":46,"centralContacts":50,"locations":60,"responsibleParty":73,"collaborators":13,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":13,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":13,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":104,"whyStopped":13,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Motor Assessments with KINARM Robot","In the arm position matching task, the robot will move one arm to a target location, and participants will match the perceived position with the opposite arm (\\~50 trials per assessment, \\~10 minutes). In the alternating reaching task, participants will make rapid alternating reaches between targets while keeping the movement within a visually defined channel or bounded path (\\~80 reaches per assessment, \\~10 minutes). In the clamped feedback reaching task, participants will complete brief sequences of center-out reaches designed to measure single-trial adaptation. Each sequence will include no-feedback reaches surrounding a trial with experimentally manipulated cursor feedback. During clamped-feedback trials, the cursor will move along a fixed path relative to the target, independent of the participant's actual hand direction. Adaptation will be estimated from changes in reach direction on subsequent no-feedback reaches (\\~120 total trials per assessment, \\~15 minutes).","From enrollment to the end of treatment at 8 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","SINGLE_GROUP","Different stimulation conditions on different days","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":21},"SINGLE",[22],"PARTICIPANT","Although diseases of the cerebellum can compromise quality of life, their treatment has received less research and clinical attention than diseases of other parts of the nervous system, such as the cerebral cortex and the spinal cord. The vision is a cerebellar prosthesis: a surgically implanted closed-loop neuromodulation system that can alleviate the symptoms of cerebellar dysfunction. Cerebellar disorders are varied, as are the opportunities for treatment. This study focuses on cerebellar disorders that impair arm and hand function as an entry point to study mechanisms of disability and treatment modalities. This first begins with exploring neuromodulation in the form of noninvasive transcranial stimulation.\n\nAim 1: Use noninvasive neuromodulation to improve upper-limb dysfunction associated with cerebellar disorders.\n\nDeficits associated with cerebellar disorders can be subtle, yet persistent and frustrating for those who experience them. Motor adaptation is a well-established cerebellum-dependent process and remains an important entry point for broader effort to understand cerebellar dysfunction and develop treatment strategies. Upper-limb dysfunction in cerebellar disorders may also reflect impairments in sensory processing, motor control, and motor learning, as well as disruption of broader cerebello-cerebral networks, including posterior parietal cortical (PPC) regions involved in sensorimotor integration and movement updating. Working hypotheses: 1. Impaired sensorimotor performance, including deficits in motor learning during a fine-grained reaching task, will be observed in individuals with cerebellar disorders, 2. These impairments will be associated with damage to sensorimotor regions of the cerebellum that will serve as future targets for an NHP stroke model, and with disruption to a functionally connected network of cerebral sensorimotor regions including PPC, 3. Intermittent theta burst stimulation (iTBS) can modulate cerebro-cerebellar circuit-level function to healthier states, improving motor control and implicit adaptation during reaching tasks.\n\nAim 1 will (i) characterize impaired reaching in individuals with cerebellar disorders, (ii) identify neuroanatomical correlates of impaired reaching, and (iii) test whether iTBS can improve reaching abilities after cerebellar dysfunction. A rigorous behavioral battery of assessments are designed to assess sensory function, motor control, and motor learning during reaching-related tasks.",[25,31,35],{"label":26,"type":27,"description":28,"interventionNames":29},"Parietal Brain Stimulation","EXPERIMENTAL","Brain stimulation will be applied to the parietal reach region.",[30],"Device: Transcranial Magnetic Stimulation",{"label":32,"type":27,"description":33,"interventionNames":34},"Cerebellar brain stimulation","Theta burst TMS stimulation will be applied over the cerebellum",[30],{"label":36,"type":37,"description":38,"interventionNames":39},"Parietal Midline Brain stimulation","SHAM_COMPARATOR","Theta burst stimulation will be applied over the parietal midline",[30],[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"DEVICE","Transcranial Magnetic Stimulation","Stimulation of continuous theta burst stimulation at 80% of resting motor threshold over the region targeted for modulation after behavioral testing, with resting of behavior afterwards.",[32,26,36],[47],{"name":48,"affiliation":5,"role":49},"Jorge A González-Martinez, MD, PhD","STUDY_DIRECTOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":13,"email":55},"George F Wittenberg, MD, PhD","CONTACT","412-648-4178","GeoWitt@Pitt.edu",{"name":57,"role":53,"phone":58,"phoneExt":13,"email":59},"Debbie Harrington, BS, CCRP","412-383-1355","debbie.harrington@pitt.edu",[61],{"facility":5,"status":13,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":13},"Pittsburgh","Pennsylvania","15213","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-79.99589,40.44062,{"lat":71,"lon":70},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","George Wittenberg","Professor","100657552","brain-stimulation-to-improvement-after-cerebellar-damage-100657552",false,"NCT07838961","Brain Stimulation to Improvement After Cerebellar Damage","Neuromodulation of Cerebellar Circuitry","Inclusion Criteria:\n\n* 18-100 years old,\n* native English speakers,\n* medically stable to participate in the study.\n\nFor those with cerebellar disorders:\n\n* presenting with a cerebellar disorder including cerebellar stroke\n* cerebellar disorder onset at least 2 weeks before enrollment.\n\nExclusion Criteria:\n\n* are unable to give consent,\n* have contractures, orthopedic problems, or other impairments that would interfere with the use of the robot or limit the range of joint motion in the potential study arm,\n* presence of medical condition or implant that prevents safe administration of stimulation (history of seizures, and\u002For taking any of the following medications: lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), topiramate (Topamax), phenytoin (Dilantin), arbamazepine (Tegretol), valproic acid (Depakote), or phenobarbital (Barbita, Luminal, Solfoton).\n* have any factor that precludes participation in a magnetic resonance imaging (MRI) session (e.g. ferrous metal in the body), or\n* have a medical condition or physical impairment precluding the ability of the participant to complete the required testing.\n* are pregnant\n\nControl participants will be excluded for the following condition:\n\n\\- have self-reported history of neurological injury or a developmental disorder",true,"ALL","18 Years","100 Years",{"count":89,"type":90},60,"ESTIMATED","INTERVENTIONAL",[93],"NA","The work will examine the mechanisms and potential therapeutic effects of transcranial magnetic stimulation on upper-limb sensorimotor function in individuals with cerebellar dysfunction, including those with damage due to stroke or autoimmune disease.\n\nThe study team will work toward a goal of non-invasive stimulation-based neuromodulatory interventions for cerebellar disorders using a closely integrated, clinically oriented cross-species approach. There will be a related study in nonhuman primates.",[96,97],"Cerebellar Stroke","Autoimmune Cerebellar Disorders",[99,100,101,102,103],"motor","transcranial magnetic stimulation","cerebellum","stroke","movement disorders","NOT_YET_RECRUITING","2026-09-18",{"date":107,"type":108},"2026-09-24","ACTUAL",{"date":110,"type":90},"2026-12",{"date":112,"type":90},"2028-12",{"name":75,"class":6},1]