The NETS Trial Collaboration Group
Neuroregeneration enhanced by transcranial direct current stimulation (tDCS) in stroke (NETS) is an investigator-initiated, interventional, prospective, randomized, double-blind, placebo-controlled trial and tested efficacy and safety of anodal tDCS (1mA, 20min) to the primary motor cortex of the lesioned hemisphere in the subacute phase (day 5-45) after cerebral ischemia.
Stimulation was combined with standardized rehabilitative training and applied in 10 sessions over 2 weeks. After 1:1 randomization of 123 patients (11 centers, 3 European countries, 2009-2019), 119 patients entered the intention-to-treat (ITT) population (mean age±SD, 66±12; 63% male). Primary outcome was upper-extremity function 1-7 days after the intervention period, measured by the upper-extremity Fugl-Meyer assessment (UEFMA). Secondary endpoints included multiple scores (e.g., ARAT, nine-hole peg test) at multiple time points up to 12 months.
Baseline variables were comparable, mean NIHSS 3.84±1.95 (IQR, 3-5), mean time since stroke 20±12 days (10-28). The intervention was well tolerated. The adjusted mean improvement of UEFMA from baseline was 9.07 in the placebo group and 8.76 with active stimulation (difference -0.31, 95% CI -2.97-2.35; p=0.820; ITT, ANCOVA). In the per-protocol analysis (94 patients), the respective UEFMA differences were 10.25 for placebo and 10.20 for active stimulation (difference -0.05, 95% CI -3.03-2.93; p=0.972). There were no relevant differences in secondary endpoints. Both groups showed very good long-term recovery (e.g., UEFMA at 12 months 56.21±9.61 [placebo] and 55.76±13.23 [active stimulation]).
In conclusion, anodal tDCS did not enhance upper extremity recovery in a cohort of mild to moderately affected subacute stroke patients.
NCT00909714