FIGURE 5.

(A) Consort Diagram for the pilot study (from Kimberley et al., 2018). Twenty-two participants were enrolled in the study of which 17 were implanted. Eight participants were randomized to the VNS group and 9 to rehabilitation only (B). Clinical study flowchart. After screening and baseline evaluations, all participants were implanted with a VNS device and randomized to receive either Active (0.8 mA) or Control VNS (0.0 mA) paired with upper limb rehabilitation. Participants received 18 sessions of in-clinic therapy for 6 weeks, followed by a home-based therapy for 3 months (no VNS was delivered to either group during the 1st month of home therapy). The 3-month time point is referred to as Post-day 90. After Post-day 90, the Active VNS group continued with home-based Active VNS, and the Control group crossed over to receive 6-weeks of in-clinic therapy with Active VNS followed by home-based Active VNS, similar to the Active VNS+Rehab group. Outcome measures were evaluated at baseline, Post-day 1, Post-day 30, and Post-day 90.