Does electrical stimulation help with functional recovery after stroke?

Noninvasive treatment with low-intensity electromagnetic network targeting field (ENTF) stimulation is safe and feasible for reducing global disability among stroke survivors, according to a study.

The study included stroke patients, enrolled 4–21 days after the index event, and had a baseline modified Rankin Scale (mRS) score of 3 or 4 (moderate or moderately severe global disability) and Fugl-Meyer Assessment for Upper Extremity score of 10–45 (higher scores indicating better arm function).

The patients were randomly assigned to receive either active or sham ENTF stimulation using a proprietary brain-computer interface–based stimulation device. Electrical stimulation was administered on top of home-based physical and occupational exercise regimen. This regimen involved 45 1-hour sessions, conducted five times per week within the first 90 days after stroke.

The trial was terminated early after recruitment of 100 patients (mean age 59.0 years, 67.3 percent male, median time from stroke to first ENTF treatment was 14 days), 50 each in the active and sham groups, due to the failure to meet the prespecified efficacy threshold at the interim analysis involving the first 78 evaluable patients.

The primary endpoint of change in global disability at day 90 did not significantly differ between the active and sham groups (mean change in mRS score, −1.96 vs −1.72). However, patients in the active group were more likely to achieve an mRS score of 0 to 1 at day 90 (26 percent vs 10 percent; odds ratio, 2.99, 95 percent confidence interval, 0.96–9.30; p=0.05).

Results for secondary outcomes favoured the active group, although the differences were not statistically significant.

In terms of safety, none of the patients in either group experienced ENTF device–related serious adverse events.

These results should be confirmed in a higher-powered pivotal trial of ENTF therapy, according to the researchers.