[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630167":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":37,"centralContacts":42,"locations":46,"responsibleParty":48,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":46,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":46,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":46},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active LIFU","EXPERIMENTAL","Participants receive transcranial Low-Intensity Focused Ultrasound (LIFU) targeting the ventral intermediate nucleus (VIM) of the thalamus, contralateral to the most affected side, delivered via the NeuroFUS PRO device (Brainbox Ltd., UK) with the following parameters: 500 kHz frequency, 5 ms pulse width, 10 Hz PRF, 5% duty cycle, ISPPA 30 W\u002Fcm². Each session consists of two 10-minute sonication blocks separated by a 20-minute interval, guided by individual MRI-based neuronavigation (Brainsight, Rogue Research).",[13],"Device: Low-Intensity Focused Ultrasound (LIFU) - NeuroFUS PRO",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham LIFU","SHAM_COMPARATOR","Participants undergo an identical procedure including transducer positioning, neuronavigation guidance, and full session duration, but no ultrasound energy is delivered to the brain. The sham condition replicates the auditory and tactile sensations of the active condition to maintain participant blinding.",[13],[20,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Low-Intensity Focused Ultrasound (LIFU) - NeuroFUS PRO","Non-invasive transcranial neuromodulation using a focused ultrasound transducer (NeuroFUS PRO, Brainbox Ltd., UK) operating at 500 kHz. Pulsed ultrasound is delivered in two 10-minute applications separated by a 20-minute interval, targeting the VIM of the thalamus under MRI-based neuronavigation. Parameters: 5 ms pulse width, 10 Hz PRF, 5% duty cycle, ISPPA 30 W\u002Fcm².",[9],[26,27,28,29],"LIFU","pulsed low-intensity focused ultrasound transcranial focused ultrasound","tFUS","TUS",{"type":21,"name":22,"description":31,"armGroupLabels":32,"otherNames":33},"Non-invasive transcranial neuromodulation using a focused ultrasound transducer (NeuroFUS PRO, Brainbox Ltd., UK) operating at 500 kHz. Pulsed ultrasound is delivered in two 10-minute applications separated by a 20-minute interval, targeting the VIM of the thalamus under MRI-based neuronavigation. Parameters: 5 ms pulse width, 10 Hz PRF, 5% duty cycle, ISPPA 30 W\u002Fcm²",[15],[26,34,35,36,28,29],"LIFUP","pulsed low-intensity focused ultrasound","transcranial focused ultrasound",[38],{"name":39,"affiliation":40,"role":41},"Rubens Gisbert Cury","Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Movement Disorders Center","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+55 11 2661-7877",null,"rubens_cury@usp.br",{"type":49,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100630167","phase-1-motor-and-non-motor-effects-of-low-intensity-focused-ultrasound-lifu-as-a-neuromodulation-tool-in-essential-tremor-100630167",false,"NCT07484152","Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Essential Tremor","Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Movement Disorders: A Randomized, Double-Blind, Sham-Controlled, Crossover Clinical Trial in Essential Tremor","LIFU-ET","Inclusion Criteria:\n\n1. Diagnosis of essencial Tremor.\n2. Presence of clinically relevant tremor despite optimized pharmacological treatment.3. Age 18-80 years.4. Ability and willingness to provide written informed consent.5. Availability to attend all scheduled study visits at HC-FMUSP.6. Availability of a brain MRI suitable for neuronavigation planning\n\nExclusion Criteria:\n\n\\- 1. Dementia syndrome or severe cognitive impairment precluding informed consent or reliable clinical assessment.\n\n2\\. Uncontrolled psychiatric disorders.3. Alcohol or illicit substance dependence.4. Use of stimulants or medications that lower seizure threshold.5. History of epileptic seizures within the last 6 months.6. Hospitalization or surgery within the last 6 months.7. Presence of implanted metallic or electronic devices in the cranium or spine that are contraindicated for focused ultrasound procedures (e.g., deep brain stimulator, cochlear implant, cardiac pacemaker, metal plates or wires).8. History of brain surgery or traumatic brain injury.9. Skull defects, craniotomy, or significant calvarial irregularities that preclude safe ultrasound delivery.10. Pregnancy or breastfeeding.11. Social impossibility of follow-up attendance.","ALL","18 Years","80 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE1","PHASE2","This study investigates the motor and non-motor effects of Low-Intensity Focused Ultrasound (LIFU) as a non-invasive neuromodulation technique in patients with essential tremor (ET) and refractory tremor. LIFU is a non-thermal, non-ablative form of transcranial focused ultrasound that modulates neural activity through mechanical mechanisms, including direct effects on neuronal membranes, alterations in membrane excitability, and modulation of synaptic transmission. Unlike high-intensity focused ultrasound (HIFU), which produces tissue ablation, LIFU induces reversible effects with a favorable safety profile, making it a promising candidate for non-invasive neuromodulation in movement disorders.\n\nIn this randomized, double-blind, sham-controlled, crossover trial, 20 patients with ET and refractory tremor will receive active LIFU targeting the ventral intermediate nucleus (VIM) of the thalamus and sham stimulation in separate sessions, separated by a washout period of at least 12 weeks. Clinical assessments using standardized and validated neurological scales will be performed before and after each session to evaluate changes in motor symptoms, tremor severity, quality of life, and non-motor features.\n\nThe primary outcome is the change in the Fahn-Tolosa-Marín Tremor Rating Scale (FTMTRS) and the Essential Tremor Rating Assessment Scale (TETRAS©). Secondary outcomes include the Patient Global Impression of Change (PGIC) and monitoring of adverse events.\n\nThis study is being conducted at the Movement Disorders Center of Hospital das Clínicas, University of São Paulo (HC-FMUSP), São Paulo, Brazil, and has been approved by the institutional ethics committee (CAPPesq; approval number 7.406.027).",[70],"Essential Tremor (ET)",[72],"essential tremor","NOT_YET_RECRUITING","2026-03-16",{"date":76,"type":77},"2026-03-19","ACTUAL",{"date":79,"type":63},"2026-03-17",{"date":81,"type":63},"2028-12-10",{"name":5,"class":6}]