Exploratory Endpoints
tremor, TPIR
Pre-specified exploratory analyses of BF-ADL scores in the mITT included assessment of improvement in BF-ADL score from baseline to one month within each arm, and improvement in individual BF-ADL tasks from baseline to one month within each arm. A two-sample t-test with Holm-Bonferroni corrections for multiple hypothesis testing was performed to compare the total and per-task changes in BF-ADL scores from baseline to the end of the month between the TX arm and SOC arm.Pre-specified exploratory analysis of tremor power in the mITT included assessment of improvement within the TX arm. Each patient’s improvement was defined as the median tremor power improvement ratio (TPIR) across all of that patient’s TAPS sessions, where TPIR was the ratio of tremor power before stimulation to after stimulation [