Department of Neurology, Stroke Division, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Palmer 127, Boston, MA, 02215, USA.
Harvard Medical School, Boston, MA, USA.
Sci Rep. 2022 Jun 10;12(1):9607. doi: 10.1038/s41598-022-14390-9.
Dysphagia is a serious stroke complication but lacks effective therapy. We investigated safety and preliminary efficacy of anodal transcranial direct current stimulation (atDCS) paired with swallowing exercises in improving post-stroke dysphagia from an acute unilateral hemispheric infarction (UHI). We conducted a double-blind, early phase-2 randomized controlled trial, in subjects (n = 42) with moderate-severe dysphagia [Penetration and Aspiration Scale (PAS) score ≥ 4], from an acute-subacute UHI. Subjects were randomized to Low-Dose, High-Dose atDCS or Sham stimulation for 5 consecutive days. Primary safety outcomes were incidence of seizures, neurological, motor, or swallowing function deterioration. Primary efficacy outcome was a change in PAS scores at day-5 of intervention. Main secondary outcome was dietary improvement at 1-month, assessed by Functional Oral Intake (FOIS) score. No differences in pre-defined safety outcomes or adjusted mean changes in PAS, FOIS scores, between groups, were observed. Post-hoc analysis demonstrated that 22 /24 subjects in the combined atDCS group had a clinically meaningful dietary improvement (FOIS score ≥ 5) compared to 8 /14 in Sham (p = 0.037, Fisher-exact). atDCS application in the acute-subacute stroke phase is safe but did not decrease risk of aspiration in this early phase trial. The observed dietary improvement is promising and merits further investigation.
吞咽困难是一种严重的中风并发症，但缺乏有效的治疗方法。我们研究了经颅直流电刺激（anodal transcranial direct current stimulation，atDCS）联合吞咽练习对急性单侧半球性梗死（unilateral hemispheric infarction，UHI）后吞咽困难的安全性和初步疗效。我们进行了一项双盲、早期 2 期随机对照试验，纳入了 42 例中重度吞咽困难（吞咽渗透和吸入量表[Penetration and Aspiration Scale，PAS]评分≥4）的急性-亚急性 UHI 患者。患者被随机分为低剂量、高剂量 atDCS 或假刺激组，连续 5 天进行治疗。主要安全性结局为癫痫发作、神经、运动或吞咽功能恶化的发生率。主要疗效结局为干预第 5 天 PAS 评分的变化。次要主要结局为 1 个月时功能性口腔摄入（Functional Oral Intake，FOIS）评分评估的饮食改善情况。未观察到各组间预定义安全性结局或 PAS、FOIS 评分调整后平均变化的差异。事后分析显示，联合 atDCS 组 22/24 例患者的饮食改善具有临床意义（FOIS 评分≥5），而假刺激组仅 8/14 例（p=0.037，Fisher 精确检验）。在急性-亚急性期应用 atDCS 是安全的，但在这项早期试验中并未降低吸入风险。观察到的饮食改善很有前景，值得进一步研究。
