[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598043":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":45,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tokyo Women's Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bilateral RF Thalamotomy","EXPERIMENTAL","Participants in this arm will undergo simultaneous bilateral radiofrequency lesioning of the ventral intermediate nucleus (Vim) of the thalamus using a stereotactic frame under local anesthesia. The procedure begins with treatment on the side contralateral to the dominant hand. Intraoperative MRI will be performed after the first lesion to confirm the absence of hemorrhagic complications. If no complications are observed, the procedure will continue on the opposite side. If hemorrhage is detected, the surgery will be terminated after unilateral treatment. The goal of this intervention is to reduce medication-refractory tremor in both upper limbs.",[13],"Procedure: Simultaneous Bilateral RF Thalamotomy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Simultaneous Bilateral RF Thalamotomy","This intervention involves simultaneous bilateral radiofrequency (RF) lesioning of the ventral intermediate nucleus (Vim) of the thalamus using a stereotactic frame under local anesthesia. The procedure begins with RF ablation on the side contralateral to the dominant hand. Intraoperative MRI is then performed to confirm the absence of hemorrhagic complications. If no bleeding or other adverse events are detected, the procedure proceeds to the contralateral Vim. If hemorrhage is identified, the surgery is terminated after unilateral treatment. This technique allows for immediate bilateral tremor reduction in patients with medication-refractory essential tremor, while prioritizing patient safety through intraoperative imaging-based decision-making.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Shiro HORISAWA, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"SHIRO Horisawa, MD","CONTACT","+81333538111","28282","neurosurgery0222@gmail.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":20,"geoPoint":20,"contacts":41},"Tokyo Women's Medical University, Department of Neurosurgery","RECRUITING","Shinjuku-Ku","Tokyo","1628666","Japan","JP",[42],{"name":43,"role":28,"phone":44,"phoneExt":30,"email":31},"Shiro Horisawa, MD","09046933702",{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Shiro Horisawa","Assistant Professor, Department of Neurosurgery","100598043","simultaneous-bilateral-radiofrequency-thalamotomy-for-medication-refractory-essential-tremor-100598043",false,"NCT07066358","Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor","Inclusion Criteria:\n\n* Adults aged 20 to 70 years.\n* Diagnosis of essential tremor by a neurologist or neurosurgeon specializing in movement disorders.\n* Refractory to standard pharmacological therapy (e.g., propranolol, primidone, benzodiazepines, or alprenolol).\n* Mini-Mental State Examination (MMSE) score ≥ 27.\n* Able to undergo MRI.\n* Provided written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* History or evidence of bleeding tendency.\n* MRI contraindications (e.g., metallic implants, severe claustrophobia).\n* Presence of intracranial pathology on preoperative MRI that would interfere with surgery.\n* Pregnant or breastfeeding individuals.\n* Any other condition that the principal investigator deems inappropriate for study participation.","ALL","20 Years","70 Years",{"count":58,"type":59},5,"ESTIMATED","INTERVENTIONAL",[62],"NA","This study aims to evaluate the safety and effectiveness of simultaneous bilateral radiofrequency thalamotomy for patients with medication-refractory essential tremor (ET). Essential tremor is a common neurological condition that causes involuntary shaking, often affecting the hands and interfering with daily activities such as writing, eating, or using tools. While medications such as propranolol and primidone can help some patients, others experience limited or no benefit.\n\nIn this study, five adult participants diagnosed with essential tremor that does not respond to standard medications will undergo simultaneous bilateral stereotactic radiofrequency lesioning of the ventral intermediate nucleus (Vim) of the thalamus. This procedure involves precisely targeting both sides of the Vim to reduce tremor in both arms during a single surgical session.\n\nPrior to surgery, participants will undergo brain MRI for surgical planning, as well as clinical evaluations including the Clinical Rating Scale for Tremor (CRST), Quality of Life in Essential Tremor Questionnaire (QUEST), the Scale for the Assessment and Rating of Ataxia (SARA), mood scales (BDI, BAI, AES), and cognitive function testing.\n\nThe surgery will be performed under local anesthesia using a stereotactic frame and intraoperative imaging. Tremor reduction will be assessed postoperatively and at 1, 3, and 6 months. The primary outcome is the improvement in CRST scores at 6 months. Secondary outcomes include quality of life (QUEST), ataxia symptoms (SARA), mood and cognitive changes, and adverse events.\n\nThis research is being conducted at Tokyo Women's Medical University. The study is IRB-approved and participants will be monitored closely throughout the 6-month follow-up period. Any complications or adverse events, such as temporary speech or swallowing difficulties, will be recorded and managed appropriately. The goal of this study is to explore whether performing thalamotomy on both sides simultaneously is a safe and effective treatment option for patients with severe and medication-resistant essential tremor.",[65],"Essential Tremor",[67,68],"thalamotomy","intraoperative MRI","2025-07-15",{"date":71,"type":72},"2025-07-18","ACTUAL",{"date":74,"type":72},"2025-07-03",{"date":76,"type":59},"2026-12",{"name":5,"class":6},1]