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RecruitingNot ApplicableNCT06974916

EMBRACE Tremor BiFUS

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

Sponsor

InSightec

Enrollment

100 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Essential Tremor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Local standard medical treatment after previous Exablate unilateral thalamotomy. and a procedure called Staged bilateral Exablate thalamotomy for people with essential tremor. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStaged bilateral Exablate thalamotomy

Staged bilateral Exablate thalamotomy in ET patients

OTHERLocal 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

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NCT06974916

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