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EMBRACE Tremor BiFUS

NCT06974916 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Günther Deuschl · Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

  • Steffen Paschen · Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2026-07-31
Completion
2028-01-31

Countries

  • Finland
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06974916 on ClinicalTrials.gov