[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632054":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":58,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"KU Leuven","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"On-target to sham","EXPERIMENTAL","Participants in this arm will receive on-target stimulation first, followed by the sham condition",[13,14],"Device: Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox","Device: Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox",{"label":16,"type":10,"description":17,"interventionNames":18},"Sham to on-target","Participants in this arm will receive sham stimulation first, followed by the on-target stimulation",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox","This study will look at both physiological tremor in healthy volunteers and pathological tremor in ET patients. A set of parameters will be tested in healthy volunteers and the optimal combination of pulse repetition frequency (PRF) and pulse duration (PD) will be selected. A closed-loop system will also be tested where the timing of the ultrasound pulses is locked to the peak or the trough of the measured tremor and can adjust in real-time.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox","This condition will serve as the active control (sham stimulation).",[9,16],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Robrecht W. Pieters, Master","CONTACT","+32 470 19 39 83","robrecht.pieters@kuleuven.be",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Myles Mc Laughlin, Professor","+32 468 24 91 64","myles.mclaughlin@kuleuven.be",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"BrainsHub","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],4.70093,50.87959,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":25,"phoneExt":25,"email":57},"Jessica Samogin, PhD","jessica.samogin@kuleuven.be",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Myles Mc Laughlin","Prof.","100632054","cerebellar-research-in-ultrasound-stimulation-100632054",false,"NCT07508696","Cerebellar Research in Ultrasound Stimulation","CERBERUS","Inclusion Criteria:\n\n* Experiment 1: Healthy Volunteers\n\n  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n  2. Participants aged 18-55 years\n  3. Male of female\n  4. Good health with no history of serious mental illness or implanted metal\n  5. Willingness to adhere to the TUS and MRI study schedule\n  6. Willingness to avoid caffeine and alcohol intake for at least 2 h prior to the investigation\n* Experiment 2: ET Patients\n\n  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n  2. Participants aged 18-75 years\n  3. Male of female\n  4. Diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist\n  5. Willingness to adhere to the TUS and MRI study schedule\n  6. Willingness to avoid caffeine and alcohol intake for at least 2 h prior to the investigation\n\nExclusion Criteria:\n\n* Experiment 1: Healthy volunteers\n\n  1. Currently taking any psychotropic medication\n  2. Any head trauma resulting in loss of consciousness\n  3. Diagnosed with a serious mental illness\n  4. Alcohol or substance abuse or dependence (other than tobacco) in the past week\n  5. Currently in treatment for a psychiatric condition\n  6. Pregnancy (a test will be scheduled by the research team)\n  7. Personal or family history of seizures or epilepsy\n  8. Claustrophobia or inability to stay still in the MR scanner environment\n  9. Any metal in the body that is not MRI-compatible\n  10. Serious history of migraines\n  11. Hair in dreadlocks, braids, or weave (not possible to position ultrasound transducer)\n  12. orthopedic forearm or hand problems\n  13. Inability to adhere to the experimental schedule.\n* Experiment 2: ET Patients\n\n  1. Currently taking any psychotropic medication\n  2. Implanted with a non-MRI compatible medical device\n  3. History of thalamotomy\n  4. Skin lesions at stimulation site\n  5. Peripheral neuropathy\n  6. neurologic exam not consistent with ET\n  7. Any head trauma resulting in loss of consciousness\n  8. Diagnosed with a serious mental illness\n  9. Alcohol or substance abuse or dependence (other than tobacco) in the past week\n  10. alcohol or caffeine consumption within 12 hours of study enrollment.\n  11. Currently in treatment for a psychiatric condition\n  12. Pregnancy (scheduled test)\n  13. Personal or family history of seizures or epilepsy\n  14. Claustrophobia or inability to stay still in the MR scanner environment\n  15. Any metal in the body that is not MRI-compatible\n  16. Serious history of migraines\n  17. Hair in dreadlocks, braids, or weave\n  18. orthopedic forearm or hand problems\n  19. Inability to adhere to the experimental schedule.",true,"ALL","18 Years","75 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","Experiment 1: Modulation of Physiological Tremor in Healthy Volunteers Thirty healthy volunteers will undergo TUS targeting the dentate nucleus in a randomized, double-blinded crossover design. Tremor amplitude, induced by a 15 g weight, will be measured using an accelerometer, and EEG will assess neural oscillations and cerebello-thalamo-cortical connectivity.\n\nStimulation will include short-term (1 minute on\u002Foff for 12 minutes) and long-term (30 minutes) protocols, as well as closed-loop TUS for phase-specific effects. This experiment aims to optimize stimulation parameters and explore the dentate nucleus's role in tremor generation.\n\nExperiment 2: Tremor Modulation in Essential Tremor Patients Thirty ET patients will receive TUS targeting the dentate nucleus with optimized parameters from Experiment 1 in a randomized crossover design. The best protocol from previous experiment will be tested here. Tremor amplitude and EEG will be recorded to assess short- and long-term effects of TUS on pathological tremor.",[81],"Essential Tremor",[83,84,81,85,86,87,88,89],"transcranial focused ultrasound stimulation","TUS","ET","Movement disorders","Neuromodulation","NIBS","non-invasive brain stimulation","NOT_YET_RECRUITING","2026-03-31",{"date":93,"type":94},"2026-04-02","ACTUAL",{"date":96,"type":75},"2026-06-01",{"date":98,"type":75},"2028-10-01",{"name":5,"class":6},1]