RecruitingNot Applicable

EMBRACE Tremor BiFUS

Finland, Germany, Italy100 participantsStarted 2025-04-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 6 Months

Trial details

NCT IDNCT06974916

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Pascalle Reiters

+31 653726776 pascaller@insightec.com

View on ClinicalTrials.gov More Essential Tremor trials