International Study Comparing Staged Bilateral Exablate Thalamotomy to Standard Treatment in Essential Tremor Patients Phase IV Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the added value of staged bilateral Exablate thalamotomy in patients with Essential Tremor who have previously undergone unilateral Exablate thalamotomy. This post-market, randomized, controlled, and blinded multicenter trial aims to compare the effects of bilateral treatment against continued unilateral treatment combined with local standard medical care. The study focuses on tremor reduction, functional abilities, quality of life, adverse events, and patient perceptions of treatment outcomes. Participants in the treatment group will receive staged bilateral Exablate thalamotomy, while those in the control group will continue with their existing unilateral treatment alongside local standard medical care. The primary goal is to assess tremor improvement at 6 months, measured by the Treated Upper Limb Clinical Rating Scale for Tremor CRST. Safety will also be evaluated by tracking adverse events related to the treatment during this period. Throughout the study, participants will undergo assessments of tremor severity using various clinical rating scales and quality of life questionnaires at 6 and 12 months. Safety monitoring will include recording any adverse events related to the treatment. Participants will be expected to complete required evaluations and remain in the study for at least 6 months, allowing researchers to gather comprehensive data on the treatments impact and safety.

EMBRACE Tremor BiFUS