EMBRACE Tremor BiFUS

NCT06974916 | Recruiting

• 1 other identifier: ET006
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side.

  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.

  6 Months

Secondary Outcomes (9)

• Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score as assessed by the blinded reviewers of the video-recordings.

  6 Months, 12 Months

• Clinical Rating Scale for Tremor (CRST) part A (0-76)

  6 Months, 12 Months

• Bilateral Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-56)

  6 Months, 12 Months

• Total Clinical Rating Scale for Tremor (CRST) (A+B) (0-116)

  6 Months, 12 Months

• Clinical Rating Scale for Tremor (CRST) part C (0-32)

  6 Months, 12 Months

Other Outcomes (5)

• Objective assessment of specific adverse events

  6 Months, 12 Months

• Patient Global Impression of Change (PGIC)

  6 Months, 12 Months

• Clinician Global Impression of Change (CGIC)

  6 Months, 12 Months

Study Arms (2)

Exablate Arm

EXPERIMENTAL

Subjects will receive staged bilateral Exablate thalamotomy.

Procedure: Staged bilateral Exablate thalamotomy

Control Arm

ACTIVE COMPARATOR

Subjects will continue with their standard of care treatment for 6 months.

Other: Local standard medical treatment after previous Exablate unilateral thalamotomy.

Interventions

Local standard medical treatment after previous Exablate unilateral thalamotomy. OTHER

Local standard medical treatment

Control Arm

Staged bilateral Exablate thalamotomy PROCEDURE

Staged bilateral Exablate thalamotomy in ET patients

Exablate Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with an age of 18 years or older.
• Willing to participate in the study (i.e., signed ICF). (Willing to be randomized).
• Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.
• Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to contrast medium should there be needed.
• The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging.
• Patient is able to communicate sensations to the physician during the procedure; Procedure does not require general anesthesia.
• Patient must be able to use the Stop Sonication button freely.
• Patient willing to have their head shaved prior to the actual treatment.
• Patient has no history for claustrophobia which is not responding to medications.
• ET patients who are eligible for second side staged bilateral Exablate thalamotomy treatment. Time since first intervention is at least 9 months.
• Available tremor assessment prior to the unilateral Exablate thalamotomy.
• Patients randomized to the study, irrespective of group allocation should be willing and able to remain in the study for at least 6 months and able to complete the required assessments.

You may not qualify if:

• Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
• Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).
• Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam.
• Patients with concurrent active infections disease and/or severe allergies with fever.
• Patients that have been diagnosed with brain tumors or a vascular anomaly.
• Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy.
• Patients under anticoagulants and/or anti-platelets drugs known to increase bleeding risk within the duration defined by the half-life of the specific drugs.
• Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment
• Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure \> 100 on medication).
• Patients with unstable cardiac status.
• Patients exhibiting any behavior(s) consistent with ethanol or substance abuse.
• Cerebrovascular disease (multiple CVA or CVA within 6 months).
• Patients with risk factors for intraoperative or postoperative bleeding.
• Imaging shows abnormal finding in CT or/and MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.).
• Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia.

Sponsors & Collaborators

• InSightec: lead

Study Sites (6)

Turku University Hospital

Turku, FI20520, Finland

RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

Kiel, 24105, Germany

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

RECRUITING

Germans Trias i Pujol Hospital

Badalona, 08916, Spain

RECRUITING

HM CINAC- Hospital Universitario HM Puerta del Sur

Móstoles, 28938, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Günther Deuschl

  Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

  PRINCIPAL INVESTIGATOR

• Steffen Paschen

  Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascalle Reiters

CONTACT

+31 653726776; pascaller@insightec.com

Insightec

CONTACT

clinicalresearchquestions@insightec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects will be videotaped while undergoing a standardized total CRST assessment at baseline and at the 6-month visit (use a standardized video-protocol). Subjects will wear head covers so that the investigator cannot tell whether the patient has received hair shaving to prepare for the FUS-intervention. Video-recordings will be assessed by two blinded core reviewers (i.e., certified Movement Disorder Neurologists, selected by the study Steering Committee (SC) for this task). The video recordings are played in random order with respect to patients and study time points to minimize reviewer bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); FI (1); DE (1); ES (3)