Abstract Body: Background and Aims: Non-invasive, frequency-tuned, low-intensity electromagnetic network targeting field (ENTF) stimulation therapy has shown signals of reducing global disability at 90 days post-stroke in subacute ischaemic stroke patients with moderate-severe disability and upper-extremity impairment in the EMAGINE 1 randomized trial, but the pace of potential response has not been delineated.
Methods: We conducted a multicenter, double-blind, randomized, sham-controlled, trial enrolling participants 4-21 days post-stroke with baseline modified Rankin Scale 3-4 and Fugl-Meyer Assessment Upper-Extremity 10-45. Participants were allocated to active or sham treatment, of stimulation paired with an evidence-based, functional, repetitive, home-based physical exercises regimen for 45 one-hour sessions, five times per week within the first 90 days from stroke. Global disability mRS was assessed at baseline, day 45, and day 90.
Results: Participant age was 59.0 (+12.5), 33% were female, and study treatment was initiated at day 14 (IQR 12-19) post-stroke. The evolution of mRS distribution in the active and sham stimulation groups is shown in the Figure. At day 45, there was evidence of potential treatment benefit for functional independence (mRS 0-2, active vs sham 50% vs 35%, adjusted p=0.05) though not in freedom-from-disability (mRS 0-1, 5% vs 2%). By day 90, after further recovery in both treatment groups, there was evidence of potential treatment benefit for both freedom-from-disability (mRS 0-1, 26% vs 11%, adjusted p=0.03) and functional independence (mRS 0-2, 83% vs 74%, p=0.13). Shift on the mRS trichotomized at 0-1/2/3-6 similarly showed signals of benefit at day 45 (adjusted p=0.07) in addition to day 90 (adjusted p=0.02).
Conclusion: ENTF therapy showed safety and preliminary efficacy in reducing global disability among subacute ischaemic stroke patients with severe baseline disability, with potential benefit accruing at mRS 0-2 by day 45 and at both mRS 0-1 and 0-2 by day 90. These results require confirmation in an adequately powered prospective trial.