ABSTRACT NUMBER: ESOC2026A2096 EXTENDING FREQUENCY-TUNED NEUROMODULATION THERAPY FROM 3 TO 6 MONTHS IS ASSOCIATED WITH SUBSTANTIAL FURTHER RECOVERY FROM POST-STROKE DISABILITY

Abstract Background and aims In two sham-controlled randomised trials, frequency-tuned electromagnetic brain stimulation [electromagnetic network-targeted field (ENTF) therapy] concurrent with rehabilitation exercises (together ENTF-CRE), started early after ischemic stroke and continued in 40-45 daily sessions, increased rates of freedom-from-disability (mRS 0-1) at 3 months. The aim of this study was to characterize extending this therapy into the 3-6-month post-stroke time period. Methods Extension stage of a multicentre, double-blind, sham-controlled, randomised clinical trial conducted at 19 US sites (EMAGINE 2). After the primary outcome 3M visit, all patients (active and sham) were offered additional active ENTF-CRE for 1-hour, five-times-per-week through 6M. Results Among 58 patients, treatment between 3-6 months was ENTF-CRE in 42 (72%), standard care (SOC) in 16 (28%). Groups were similar in age (59.9 vs 60.3), sex, and pretreatment mRS (3.9 vs 3.9). At 6M, freedom-from-disability (mRS 0-1) was more common in patients in the ENTF-CRE group, 34.4% vs 0%, p=0.009. Disability level (mRS shift) was lower in ENTF-CRE group (Figure, p=0.03). Patient-reported outcomes showed greater improvement from 3M to 6M in hand function (SIS-Hand, +1.7 vs -0.1, p=0.046) and physical function (SIS-16, +4.3 vs -2.1, p=0.003). Conclusions ENTF-CRE delivered in the 3-6 month time period is associated with substantial increase in excellent global disability outcome (mRS 0-1, freedom-from-disability). These findings suggest ENTF therapy should be extended through at least 6 months and should be explored for additional benefit in the chronic, ≥6 month post-stroke time period. Conflict of interest Drs. Saver, Stein, Cramer, Sheth, and Bornstein have a financial relationship with the sponsor of the trial, BrainQ Technologies, Ltd. Dr. Billinger has nothing to disclose. Figure 1 - belongs to Results