Table 4:
Time Point | Mean Score (SD) | Mean Improvement vs. Baseline | Mean Difference, Points (95% CI) | P Value | ||
---|---|---|---|---|---|---|
MRgFUS | Sham | MRgFUS | Sham | |||
Baseline | 50.1 (14.0) | 44.1 (12.7) | – | – | – | NS |
3 months | 29.6 (13.0) | 43.1 (13.1) | 41% | 2% | NR | < .001a |
12 months | 32.4 (14.5) | NAb | 35% | NAb | NR | NA |
Abbreviations: CI, confident interval; MRgFUS, magnetic resonance-guided focused ultrasound; NA, not applicable; NS, not significant; SD, standard deviation.
Note: Overall tremor severity was assessed via parts A, B, and C of the Clinical Rating Scale for Tremors (CRST), where higher scores indicate greater tremor severity. The maximum possible score is 152.
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 differences from baseline for the MRgFUS thalamotomy group was reported for the 12-month time point.
Source: Elias et al, 2016.38