Efficacy assessment—unblinded
Anxiety, spasticity, anxiety, depression, Depression
SECONDARY
All efficacy assessments were performed, unblinded and in person, as secondary measures for this phase 1 trial. Data were collected monthly from the presurgical baseline through 4 months after the DBS + rehab phase (Fig. Several other secondary measures were collected as part of this initial phase I exploration, including the Nine-Hole Peg Test, the Bilateral Box and Block Test, the Bimanual Grip Test, the Modified Ashworth Scale, the Short Form Health Survey (SF-12), the EQ-5D, the Beck Anxiety Inventory and the Beck Depression Inventory. These additional secondary metrics were included to monitor for any possible (then unknown) effects of DN-DBS on non-motor domains, including effects on spasticity, anxiety and depression; however, no significant changes were observed in this limited sample. A complete listing of secondary endpoints is provided in the Supplementary Table 