Study endpoints
tremor, Tremor, TPIR
SECONDARY
The primary endpoint was improvement in tremor power. Wrist-worn accelerometer recordings of postural holds, before and immediately after therapy sessions of 40 minutes were included in the primary endpoint results. Tremor power improvement ratio (TPIR) was calculated as the ratio of tremor power from pre- to post-stimulation postural holds over each valid session in each patient [The secondary endpoints were improvement in clinician-ratings of action tremor, defined as the average change per-task in MDS-UPDRS 3.15 (postural tremor of the hands) and MDS-UPDRS 3.16 (kinetic tremor of the hands), and patient-ratings of upper limb activities of daily living, defined as the average change per-task in the eight assessed BF-ADL tasks. Each of these were analyzed in the dominant hand from before the supervised stimulation session in visit 1 to after the stimulation session in visit 2, as well as before to after the stimulation session within each visit. The exploratory endpoints included CGI-I, PGI-I, and improvement and responder rate of individual tasks in MDS-UPDRS III and BF-ADL. Responder rates were defined as percent of patients improved by at least one point following stimulation of whom rated at least mildly impaired in the assessed task (i.e., MDS-UPDRS III or BF-ADL score ≥ 2). Patients whose PD-related medications were changed during the study were excluded from the secondary endpoint analyses.The order of endpoints for statistical analysis were pre-defined in the statistical analysis plan. Analysis began with the primary endpoint, TPIR, followed by secondary endpoints, MDS-UPDRS and BF-ADL. The primary endpoint was analyzed using one-sample Wilcoxon’s signed-rank test to determine whether TPIR (primary endpoint) was greater than 1 with one-sided 