Percutaneous Mastoid Electrical Stimulator improves poststroke depression and cognitive function in patients with ischemic stroke:A Prospective, Randomized, Double-blind, and Sham-controlled Study

Abstract

Backgrond: Poststroke depression could lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of percutaneous mastoid electrical stimulator (PMES) plus antidepressant on poststroke depression and cognitive function. Methods: This study was a prospective, randomized, double-blind, and sham-controlled study. 258 clinically depressed ischemic stroke patients within 14 d of index stroke were randomly assigned to PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133). All patients underwent Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months after the stroke. Primary outcomes were the percentage of treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. Secondary outcome was the percentage of MoCA score <26. Results: The percentage of treatment response and depression remission in PMES group were significantly higher than that in the sham group (57.60% vs 41.35%, P=0.009), (44.00% vs 29.32%, P=0.014), respectively. The mean value of HRSD score change(M6-baseline) was significantly greater in the PMES group compared to sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036). The percentage MoCA score <26 in PEMS group was lower than that in sham group(12.0% vs 24.06%, P=0.012), the mean value of MoCA score change (M6-baseline) was higher in PMES group compared to sham group (3.50±2.55 vs 2.72±2.52; P=0.005). Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018