🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06974916
Recruiting Not applicable

EMBRACE Tremor BiFUS

NCT06974916 · tracked via the Priya Life Science UK tracker
Sponsor
InSightec
Phase
Not applicable
Started
2025-04-22
Last updated
2026-08-31

Condition(s) studied

Essential Tremor

Investigational drug(s) / intervention(s)

Staged bilateral Exablate thalamotomyLocal standard medical treatment after previous Exablate unilateral thalamotomy.

Staged bilateral Exablate thalamotomy: Staged bilateral Exablate thalamotomy in ET patients

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Men and women with an age of 18 years or older (according to local labeling). 2. Willing to participate in the study (i.e., signed ICF). (Willing to be randomized). 3. Patient is able to undergo a high-resolution Computerized Tomography (CT) scan. 4. 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. 5. The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging. 6. Patient is able to communicate sensations to the physician during the procedure; Procedure does not require general anesthesia. 7. Patient must be able to use the Stop Sonication button freely. 8. Patient willing to have their head shaved prior to the actual treatment. 9. Patient has no history for claustrophobia which is not responding to medications. 10. ET patients who are eligible for second side staged bilateral Exablate thalamotomy treatment (according to local labeling). Time since first intervention is at least 9 months. 11. Available tremor assessment prior to the unilateral Exablate thalamotomy. 12. 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. Exclusion Criteria: 1. Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure. 2. Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium). 3. 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. 4. Patients with concurrent active infections disease and/or severe allergies with fever. 5. Patients that have been diagnosed with brain tumors or a vascular anomaly. 6. Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy. 7. 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. 8. Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment 9. Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure \> 100 on medication). 10. Patients with unstable cardiac status. 11. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse. 12. Cerebrovascular disease (multiple CVA or CVA within 6 months). 13. Patients with risk factors for intraoperative or postoperative bleeding. 14. Imaging shows abnormal finding in CT or/and MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.). 15. Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia. 16. Patient with cognitive impairment. 17. Patient with clinically significant abnormal speech function as determined by a speech pathologist.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Turku University Hospital Turku Finland Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH) Kiel Germany Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy Recruiting
Central Japan International Medical Center Minokamo Gifu Not Yet Recruiting
Kashiwaba Neurology Hospital Sapporo Hokkaido Not Yet Recruiting
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai Kita-ku Osaka Not Yet Recruiting
Germans Trias i Pujol Hospital Badalona Spain Recruiting
HM CINAC- Hospital Universitario HM Puerta del Sur Móstoles Spain Recruiting
Clinica Universidad de Navarra Pamplona Spain Recruiting
Ascires Hospital_ECG Salud Valencia Spain Active Not Recruiting
Chang Bing Show Chwan Memorial Hospital Changhua Taiwan Recruiting
National Taiwan University Hospital Taipei Taiwan Not Yet Recruiting
The Walton Center Liverpool United Kingdom Not Yet Recruiting

More InSightec trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06974916 on ClinicalTrials.gov ↗ ← All trials in the UK