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Summary
This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment.
Official title: International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-04-22
Completion Date
2028-03
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Staged bilateral Exablate thalamotomy
Staged bilateral Exablate thalamotomy in ET patients
Local standard medical treatment after previous Exablate unilateral thalamotomy.
Local standard medical treatment
Locations (13)
Turku University Hospital
Turku, Finland
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
Kiel, Germany
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Central Japan International Medical Center
Minokamo, Gifu, Japan
Kashiwaba Neurology Hospital
Sapporo, Hokkaido, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai
Kita-ku, Osaka, Japan
Germans Trias i Pujol Hospital
Badalona, Spain
HM CINAC- Hospital Universitario HM Puerta del Sur
Móstoles, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Ascires Hospital_ECG Salud
Valencia, Spain
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
The Walton Center
Liverpool, United Kingdom