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| Non-invasive brain stimulation can reduce unilateral spatial neglect after stroke: ELETRON trial |
| da Silva TR, de Carvalho Nunes HR, Martins LG, da Costa RDM, de Souza JT, Winckler FC, Sartor LCA, Modolo GP, Ferreira NC, da Silva Rodrigues JC, Kanda R, Fogarolli MO, Borges GF, Rizzatti GRS, Ribeiro PW, Favoretto DB, Aguiar L, Zanati Bazan SG, Betting LEG, de Oliveira Antunes LC, Mendes Pereira V, Santos TEG, Pontes-Neto O, Conforto AB, Bazan R, Luvizutto GJ |
| Annals of Neurology 2022 Sep;92(3):400-410 |
| clinical trial |
| 7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Rehabilitation top-down techniques based on brain stimulation present variable outcomes in unilateral spatial neglect (USN) after stroke. This study aimed to examine the effects of physical therapy after anodal and cathodal direct current stimulation (A-tDCS and C-tDCS, respectively) to improve visuospatial and functional impairments in individuals with USN after stroke. METHODS: This double-blinded, pilot randomized clinical trial enrolled patients with USN after ischemic stroke. Randomization was stratified according to Behavior Inattention Test Conventional (BIT-C) and Catherine Bergego Scale (CBS). Outpatient physical therapy was conducted for 7.5 weeks after 20 min of tDCS. The primary outcome was the USN degree evaluated by the BIT-C. Secondary outcomes were the difference in CBS score, stroke severity (National Institutes of Health Stroke Scale (NIHSS)), disability (modified Rankin Scale (mRS)), autonomy (Barthel Index (BI), functional independence measure (FIM)), and quality of life (EQ-5D). Outcomes were analyzed using ANCOVA model corrected by age, baseline NIHSS and baseline BIT-C. Pairwise posthoc comparisons were performed using Bonferroni correction. RESULTS: In the primary outcomes, A-tDCS led to greater improvement in BIT-C after intervention (MD 18.4; 95%CI 3.9 to 32.8; p = 0.008) compared to sham. However, no significant differences were observed between A-tDCS and C-tDCS (MD 13.9; 95%CI -0.3 to 28.1; p = 0.057), or C-tDCS and sham (MD 4.5; 95%CI -9.7 to 18.8; p = 0.99). There were no significant differences between groups in terms of secondary outcomes. CONCLUSIONS: A-tDCS associated with physical therapy can decrease the severity of USN after stroke. However, these preliminary findings must be confirmed by collecting additional evidence in a larger phase III trial. REGISTRATION: URL: https://ensaiosclinicos.gov.br/; Unique Identifier RBR-78jvzx
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