Table 3:
Intention-to-Treat Analysis of Upper Extremity Tremor Severity—MRgFUS Thalamotomy Versus Sham
| Time Point | Mean Score (SD) | Mean Improvement vs. Baseline | Mean Difference, Points (95% CI) | P Value | ||
|---|---|---|---|---|---|---|
| MRgFUS | Sham | MRgFUS | Sham | |||
| Baseline | 18.1 (4.8) | 16.0 (4.4) | – | – | – | NS |
| 3 months | 9.6 (5.1) | 15.8 (4.9) | 47% | 0.1% | −8.3 (−5.9 to −10.7) | < .001a |
| 12 months | 10.9 (4.5) | NAb | 40% | NAb | −7.2 (−6.1 to −8.3) | < .001c |
Abbreviations: CI, confident interval; MRgFUS, magnetic resonance-guided focused ultrasound; NA, not applicable; NS, not significant; SD, standard deviation.
Note: Upper extremity tremor severity was assessed via parts A and B of the Clinical Rating Scale for Tremors (CRST), where higher scores indicate greater severity. The maximum possible score is 32.
a
P value is for the between-groups difference at 3 months follow up.
b
After the 3-month blinded period, sham participants could cross over to receive MRgFUS thalamotomy.
c
P value is for the change from baseline within the MRgFUS thalamotomy group.
Source: Elias et al, 2016.38