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RECRUITING
NCT06974916
NA

EMBRACE Tremor BiFUS

Sponsor: InSightec

View on ClinicalTrials.gov

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: European, 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

2028-01

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

PROCEDURE

Staged bilateral Exablate thalamotomy

Staged bilateral Exablate thalamotomy in ET patients

OTHER

Local standard medical treatment after previous Exablate unilateral thalamotomy.

Local standard medical treatment

Locations (6)

Turku University Hospital

Turku, Finland

Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

Kiel, Germany

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Germans Trias i Pujol Hospital

Badalona, Spain

HM CINAC- Hospital Universitario HM Puerta del Sur

Móstoles, Spain

Clinica Universidad de Navarra

Pamplona, Spain