Table 8:
Time Point | Mean Score (SD) | Mean Improvement vs. Baseline | P Value | ||
---|---|---|---|---|---|
MRgFUS | Sham | MRgFUS | Sham | ||
Baseline | 16.5 (4.6) | 16.0 (4.3) | – | – | NS |
3 months | 6.2 (5.6) | 15.6 (4.6) | 62% | 3% | < .001a |
12 months | 6.3 (6.2) | NAb | 62% | NAb | NA |
Abbreviations: MRgFUS, magnetic resonance-guided focused ultrasound; NA, not applicable; NS, not significant; SD, standard deviation.
Note: Functional disability was assessed via part C of the Clinical Rating Scale for Tremors (CRST), where higher scores indicate greater severity. The maximum possible score is 32.
P value is for the between-groups difference at 3 months follow up.
After the 3-month blinded period, sham participants could cross over to receive MRgFUS thalamotomy. Only the within-group difference from baseline for the MRgFUS thalamotomy group was reported for the 12-month time point.
Source: Elias et al, 2016.38