A Randomized, Double-Blind, Sham-Controlled Study of Transcranial Direct Current Stimulation as an Augmentation Intervention for the Attenuation of Motor Deficits in Patients With Stroke

Abstract

Introduction: Most studies of transcranial direct current stimulation (tDCS) for motor deficits in patients with stroke administered few sessions of tDCS and with low current amplitude.Methods: During 2015 to 2019, we randomized 60 inpatients with ischemic/hemorrhagic stroke and motor deficits to true or sham tDCS. Transcranial direct current stimulation was administered at 2-to 3-mA current strength, twice daily, 6 days a week, for 2 weeks; anode and cathode were placed over ipsilesional and contralesional motor cortices, respectively. All patients received individualized motor and cognitive rehabilitation. Motor outcomes were assessed 1 day before and 1 day after the tDCS course using the Fugl-Meyer Assessment, the Jebson-Taylor Hand Function Test, and the Barthel index (all coprimary outcomes). Mood and cognition were also assessed. Motor outcomes were compared between groups using age, baseline scores, and latency to treatment as covariates. The study was prospectively registered (CTRI/2017/01/007733). Results:The mean age of the patients was 46.9 years. The sample was 73.3% male. Six patients did not complete the study. The covariates were significantly related to motor outcomes. Although all patients showed motor improvements, after adjusting for covariates, tDCS was not superior to sham treatment on any motor, mood, or cognitive outcome. Laterality of hemispheric lesion influenced spatial but not motor outcomes with tDCS. One true tDCS patient developed blistering under the anode and was withdrawn from the study; 3 more reported transient itching during sessions.Conclusions: An intensive course of tDCS, as delivered in this study, does not improve motor, mood, and cognitive outcomes in ischemic/hemorrhagic stroke in patients undergoing individualized rehabilitation. The study provides important leads for directions for future research.

Influence of Transcranial Direct Current Stimulation Dosage and Associated Therapy on Motor Recovery Post-stroke: A Systematic Review and Meta-Analysis

“…The number of participant assessed with the BI, the upper extremity FMA, the lower extremity FMA, and the MAS tested was 515, 913, 179, and 172, respectively. Despite all the studies being randomized controlled trials, out of the 31 studies that were included in this review, one study reported significant differences between the tDCS and sham groups at baseline (Pinto et al, 2021) and some studies made no mention of baseline differences either in their discussion or with a statistical analysis (Allman et al, 2016;Achacheluee et al, 2018;Oveisgharan et al, 2018). The rest of the included studies reported that the sham and tDCS groups were similar at baseline.…”

“…Some manuscripts reported more than one assessment. Ten of them investigated the BI (Kim et al, 2010;Hesse et al, 2011;Khedr et al, 2013;Fusco et al, 2014;Yi et al, 2016;Koo et al, 2018;Bolognini et al, 2020;Bornheim et al, 2020;Yao et al, 2020;Pinto et al, 2021), 25 included the upper extremity FMA (Lindenberg et al, 2010;Bolognini et al, 2011Bolognini et al, , 2020Hesse et al, 2011;Nair et al, 2011;Khedr et al, 2013;Rossi et al, 2013; FIGURE 1 | Effects of transcranial direct current stimulation (tDCS) on stroke recovery as assessed by the post-intervention data of the tDCS and sham groups for the Barthel Index. Fusco et al, 2014;Viana et al, 2014;Ang et al, 2015;Triccas et al, 2015;Allman et al, 2016;Kim et al, 2016;Rocha et al, 2016;Straudi et al, 2016;Yi et al, 2016;Mazzoleni et al, 2017;Achacheluee et al, 2018;Oveisgharan et al, 2018;Beaulieu et al, 2019;Edwards et al, 2019;Jin et al, 2019;Alisar et al, 2020;Bornheim et al, 2020;Liao et al, 2020;Yao et al, 2020;Pinto et al, 2021;Prathum et al, 2021), five included the lower extremity FMA (Chang...…”

“…Three subgroups of therapy types were previously suggested (Elsner et al, 2020) and used in this review: (1) conventional (e.g., physical therapy or occupational therapy); ( 2) assisted (e.g., mirror, virtual reality, robot-assisted, or brain-computer interface-assisted motor imagery); and (3) miscellaneous (e.g., constraint-induced movement therapy). In these comparisons one study was excluded because it used a combination of two of the subgroups (Pinto et al, 2021).…”

“…No study was included in the miscellaneous therapy subgroup. One study was excluded from this calculation because it used a combination of assisted and conventional therapies (Pinto et al, 2021).…”

Comparative efficacy of different noninvasive brain stimulation therapies for recovery of global cognitive function, attention, memory, and executive function after stroke: a network meta-analysis of randomized controlled trials

“…There is so far conflicting evidence from systematic reviews of randomized controlled trials (RCTs) on the effectiveness of different NIBS approaches for improving different domains of cognitive function after stroke. New RCTs on TMS and tDCS 13,24,35,36,37 were not included in the prior meta-analysis. To acquire integrated results, it is required to expand these investigations.…”