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Studies

Interventional Recruiting

NCT06974916 on ClinicalTrials.gov

EMBRACE Tremor BiFUS

Official title: International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS

  • Sponsor: InSightec (Israel)
  • Enrollment: 100 (Estimated)
  • Study start: 2025-04-22 (Actual)
  • Primary completion: 2027-07-01 (Estimated)
  • Study completion: 2028-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Essential Tremor

Intervention / Treatment

  • Procedure: Staged bilateral Exablate thalamotomy
  • Other: Local standard medical treatment after previous Exablate unilateral thalamotomy.

Primary Outcome Measures

  • Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side. (6 Months)
    The primary endpoint is the difference of the Treated Upper Limb CRST (A+B) score between groups at 6 months. Higher score means a worse tremor.

Countries

Finland, Germany, Italy, Japan, Spain, Taiwan, United Kingdom

Locations and Investigators

  • Turku University Hospital, Turku, Finland (Recruiting)
    • Valtteri Kaasinen
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Kiel, Germany (Recruiting)
  • Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (Recruiting)
    • Roberto Eleopra
  • Central Japan International Medical Center, Minokamo, Japan (Not yet recruiting)
    • Daisuke Nakatsubo
    • Daisuke Nakatsubo (Principal Investigator)
  • Kashiwaba Neurology Hospital, Sapporo, Japan (Not yet recruiting)
    • Takuhito Narita
    • Takuhito Narita (Principal Investigator)
  • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai, Kita-ku, Japan (Not yet recruiting)
    • Hiroki Toda
    • Hiroki Toda (Principal Investigator)
  • Germans Trias i Pujol Hospital, Badalona, Spain (Recruiting)
    • Dolores Vilas Rolán
  • HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, Spain (Recruiting)
    • Raul Martinez Fernandez
  • Clinica Universidad de Navarra, Pamplona, Spain (Recruiting)
    • Maria Cruz Rodriguez Oroz
  • Ascires Hospital_ECG Salud, Valencia, Spain (Active not recruiting)
  • Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan (Recruiting)
    • Pei-Han Wu
    • Pei-Han Wu (Principal Investigator)
  • National Taiwan University Hospital, Taipei, Taiwan (Not yet recruiting)
    • Yung-Tsai Chu
    • Yung-Tsai Chu (Principal Investigator)
  • The Walton Center, Liverpool, United Kingdom (Not yet recruiting)
    • Jibril Farah

Study Officials