Focused ultrasound treatment for essentialtremor highly effective after 5 years uva
Annually, at years 2 through 5, assessments were performed to assess long-term safety, effectiveness, and quality of life. Any study participant who underwent a subsequent intervention for ET on their treated side at any point during the 5-year follow-up period was excluded from further analysis.
After patient preparation and positioning, stereotactic targeting with the use of MRI and patient neurological feedback was utilized to identify the Vim nucleus of the thalamus. Acoustic energy was gradually titrated to achieve thermal ablation, with peak voxel temperatures of 55°C–60°C in the target region. Real-time MR thermometry was monitored, and patients were continually assessed for safety and tremor response throughout the procedure.
A secondary measure of effectiveness was the Quality of Life in Essential Tremor Questionnaire , a 30-item, self-reported questionnaire that assesses the effect of tremor symptoms on activities of daily living.To evaluate safety, the long-term incidence and severity of adverse events were noted at all study follow-ups. All AEs were categorized by the investigators as definitely, probably, possibly, or not related to the device or study procedure.
Descriptive statistics were applied to calculate the significance of the mean score reduction per visit: paired t-tests were used to calculate p values to show the likelihood of the observed differences between baseline and each long-term follow-up time point was used. A p value < 0.05 was considered statistically significant. Mean values are expressed with the standard deviation.Seventy-six patients were enrolled in the original protocol, 56 in the treatment arm and 20 in the sham arm.
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