Efficacy and safety of transcranial direct current stimulation to the ipsilesional motor cortex in subacute stroke (NETS): a multicenter, randomized, double-blind, placebo-controlled trial
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Efficacy and safety of transcranial direct current stimulation to the ipsilesional motor cortex in subacute stroke (NETS): a multicenter, randomized, double-blind, placebo-controlled trial. / NETS Trial Collaboration Group.
In: LANCET REG HEALTH-EU, Vol. 38, 100825, 03.2024, p. 100825.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Efficacy and safety of transcranial direct current stimulation to the ipsilesional motor cortex in subacute stroke (NETS): a multicenter, randomized, double-blind, placebo-controlled trial
AU - NETS Trial Collaboration Group
AU - Cordes, Diana
AU - Gerloff, Christian
AU - Heise, Kirstin-Friederike
AU - Hummel, Friedhelm C
AU - Schulz, Robert
AU - Wolf, Silke
AU - Haevernick, Kerstin
AU - Krüger, Heike
AU - Krause, Linda
AU - Suling, Anna
AU - Wegscheider, Karl
AU - Zapf, Antonia
AU - Dressnandt, Jürgen
AU - Schäpers, Barbara
AU - Schrödl, Christoph
AU - Hauptmann, Björn
AU - Kirchner, Anja
AU - Brault, Anna
AU - Gutschalk, Alexander
AU - Richter, Constanze
AU - Nowak, Dennis A.
AU - Veldema, Jitka
AU - Koch, Giacomo
AU - Maiella, Michele
AU - Dohle, Christian
AU - Jettkowski, Katrin
AU - Pilz, Mario
AU - Hamzei, Farsin
AU - Olischer, Lydia
AU - Renner, Caroline
AU - Groß, Marcus
AU - Jöbges, Michael
AU - Voller, Bernhard
PY - 2024/3
Y1 - 2024/3
N2 - BACKGROUND: Each year, five million people are left disabled after stroke. Upper-extremity (UE) dysfunction is a leading problem. Neuroplasticity can be enhanced by non-invasive brain stimulation (NIBS) but evidence from large, randomized multicenter trials is lacking. We aimed at demonstrating efficacy of NIBS to enhance motor recovery after ischemic stroke.METHODS: We randomly assigned patients to receive anodal transcranial direct current (tDCS, 1 mA, 20 min) or placebo stimulation ('control') over the primary motor cortex of the lesioned hemisphere in addition to standardized rehabilitative training over ten days in the subacute phase after stroke. The original study was planned to enrol 250 but, following a blinded interim analysis, ended with 123 participants. The primary outcome parameter was UE impairment, measured by UE-Fugl-Meyer-Assessment (UEFMA), one to seven days after the end of the treatment intervention (ClinicalTrials.gov, NCT00909714).FINDINGS: From 2009 to 2019, 123 patients were included, with 119 entering intention-to-treat analysis (ITT). The control group (N = 61) improved 8.9 (SD 7.7) UEFMA points, the tDCS group (N = 58) improved 9.0 (8.8) points. ITT was neutral with respect to the primary efficacy endpoint (p = 0.820). We found no difference in UEFMA change between active tDCS and control. The safety profile of tDCS was favorable. In particular, there were no seizures.INTERPRETATION: In patients with ischemic stroke, anodal tDCS applied to the motor cortex of the lesioned hemisphere over 10 days in the subacute phase was safe but did not improve the recovery of upper extremity function compared with placebo stimulation.FUNDING: Deutsche Forschungsgemeinschaft (GE 844/4-1).
AB - BACKGROUND: Each year, five million people are left disabled after stroke. Upper-extremity (UE) dysfunction is a leading problem. Neuroplasticity can be enhanced by non-invasive brain stimulation (NIBS) but evidence from large, randomized multicenter trials is lacking. We aimed at demonstrating efficacy of NIBS to enhance motor recovery after ischemic stroke.METHODS: We randomly assigned patients to receive anodal transcranial direct current (tDCS, 1 mA, 20 min) or placebo stimulation ('control') over the primary motor cortex of the lesioned hemisphere in addition to standardized rehabilitative training over ten days in the subacute phase after stroke. The original study was planned to enrol 250 but, following a blinded interim analysis, ended with 123 participants. The primary outcome parameter was UE impairment, measured by UE-Fugl-Meyer-Assessment (UEFMA), one to seven days after the end of the treatment intervention (ClinicalTrials.gov, NCT00909714).FINDINGS: From 2009 to 2019, 123 patients were included, with 119 entering intention-to-treat analysis (ITT). The control group (N = 61) improved 8.9 (SD 7.7) UEFMA points, the tDCS group (N = 58) improved 9.0 (8.8) points. ITT was neutral with respect to the primary efficacy endpoint (p = 0.820). We found no difference in UEFMA change between active tDCS and control. The safety profile of tDCS was favorable. In particular, there were no seizures.INTERPRETATION: In patients with ischemic stroke, anodal tDCS applied to the motor cortex of the lesioned hemisphere over 10 days in the subacute phase was safe but did not improve the recovery of upper extremity function compared with placebo stimulation.FUNDING: Deutsche Forschungsgemeinschaft (GE 844/4-1).
U2 - 10.1016/j.lanepe.2023.100825
DO - 10.1016/j.lanepe.2023.100825
M3 - SCORING: Journal article
C2 - 38476746
VL - 38
SP - 100825
JO - LANCET REG HEALTH-EU
JF - LANCET REG HEALTH-EU
SN - 2666-7762
M1 - 100825
ER -
