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Fostering eating after stroke (FEASt) trial for improving post-stroke dysphagia with non-invasive brain stimulation.

ABSTRACT: 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.

SUBMITTER: Kumar S

PROVIDER: S-EPMC9187742 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Fostering eating after stroke (FEASt) trial for improving post-stroke dysphagia with non-invasive brain stimulation.

Kumar Sandeep S Marchina Sarah S Langmore Susan S Massaro Joseph J Palmisano Joseph J Wang Na N Searls David Eric DE Lioutas Vasileios V Pisegna Jessica J Wagner Cynthia C Shinde Anant A Schlaug Gottfried G

Scientific reports 20220610 1

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 ...[more]

PMID: 35689084

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Project description:BackgroundDysphagia is a common sequelae after stroke. Noninvasive brain stimulation (NIBS) is a tool that has been used in the rehabilitation process to modify cortical excitability and improve dysphagia.ObjectiveTo systematically evaluate the effect of NIBS on dysphagia after stroke and compare the effects of two different NIBS.MethodsRandomized controlled trials about the effect of NIBS on dysphagia after stroke were retrieved from databases of PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang Data, VIP, and CBM, from inception to June 2021. The quality of the trials was assessed, and the data were extracted according to the Cochrane Handbook for Systematic Reviews of Interventions. A statistical analysis was carried out using RevMan 5.3 and ADDIS 1.16.8. The effect size was evaluated by using the standardized mean difference (SMD) and a 95% confidence interval (CI).ResultsUltimately, 18 studies involving 738 patients were included. Meta-analysis showed that NIBS could improve the dysphagia outcome and severity scale (DOSS) score (standard mean difference (SMD) = 1.44, 95% CI 0.80 to 2.08, P < 0.05) and the water swallow test score (SMD = 6.23, 95% CI 5.44 to 7.03, P < 0.05). NIBS could reduce the standardized swallowing assessment (SSA) score (SMD = -1.04, 95% CI -1.50 to -0.58, P < 0.05), the penetration-aspiration scale (PAS) score (SMD = -0.85, 95% CI -1.33 to -0.36, P < 0.05), and the functional dysphagia scale score (SMD = -1.05, 95% CI -1.48 to -0.62, P < 0.05). Network meta-analysis showed that the best probabilistic ranking of the effects of two different NIBS on the DOSS score is rTMS (P = 0.52) > tDCS (P = 0.48), the best probabilistic ranking of the SSA score is rTMS (P = 0.72) > tDCS (P = 0.28), and the best probabilistic ranking of the PAS score is rTMS (P = 0.68) > tDCS (P = 0.32).ConclusionExisting evidence showed that NIBS could improve swallowing dysfunction and reduce the occurrence of aspiration after stroke, and that rTMS is better than tDCS. Limited by the number of included studies, more large-sample, multicenter, double-blind, high-quality clinical randomized controlled trials are still needed in the future to further confirm the results of this research.

Project description:IntroductionNon-invasive brain stimulation (NIBS) with speech therapy might improve recovery from post-stroke aphasia. This three-armed sham-controlled blinded prospective proof-of-concept study tested 1 Hz subthreshold repetitive transcranial magnetic stimulation (rTMS) and 2-mA cathodal transcranial direct current stimulation (ctDCS) on the right pars triangularis in subacute post-stroke aphasia.Patients and methodsSixty-three patients with left middle cerebral artery infarcts were recruited in five hospitals (Canada/United States/Germany, 01-2014/03-2018) and randomized to receive rTMS (N = 20), ctDCS (N = 24) or sham stimulation (N = 19) with ST for 10 days. Primary outcome variables were Z-score changes in naming, semantic fluency and comprehension tests and adverse event frequency. Secondary outcome variable was the percent change in the Unified Aphasia Score. Intention-to-treat analyses tested between-group effects at days 1 and 30 post-treatment with a pre-planned subgroup analysis for lesion location (affecting Broca's area or not).ResultsNaming was significantly improved by rTMS (median = 1.91/interquartile range = 0.77/p = .01) at 30 days versus ctDCS (median = 1.11/interquartile range = 1.51) and sham stimulation (median = 1.02/interquartile range = 1.71). All other primary results were non-significant. The rTMS effect was driven by the patient subgroup with intact Broca's area where NIBS tended to improve UnAS (median = 33.2%/interquartile range = 46.7%/p = .062) versus sham stimulation (median = 12.5%/interquartile range = 7.9%) at day 30. Conversely, in patients with infarcted Broca's area, UnAS tended to improve more with sham stimulation (median = 75.0%/interquartile range = 86.9%/p = .053) versus NIBS (median = 12.7%/interquartile range = 31.7).Conclusion: We found a delayed positive effect of low-frequency rTMS targeting the right pars triangularis on the recovery of naming performance in subacute post-stroke aphasia. This intervention may be beneficial only in patients with morphologically intact Broca's area.

Project description:Dysphagia is one of the most common symptoms in patients after stroke onset, which has multiple unfavorable effects on quality of life and functional recovery. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation that is widely used to improve deglutition function. Recently, some studies have confirmed that tDCS enhances deglutition function after stroke. However, the number of evaluation indexes used in those studies was small, and the number of trials included was limited. Most importantly, the optimal stimulation protocol is still uncertain and the safety of tDCS has not been reviewed. Therefore, we conducted a systematic review and meta-analysis to address these shortcomings.MethodsSeven databases were searched entirely, including Pubmed, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Service System (SinoMed), Wan-fang database, and the Chinese Scientific Journals Database (VIP) from inception to 31 December 2021. Two reviewers independently evaluated the eligibility of retrieved data according to the selection criteria and assessed the methodological quality of the studies using the Cochrane risk of bias tool. Outcomes, measures, and indicators used in this study included the dysphagia outcome and severity scale (DOSS), modified Mann assessment of swallowing ability (MMASA), functional oral intake scale (FOIS), functional dysphagia scale (FDS), and Kubota's water-drinking test (KWDT). Sensitivity and subgroup analyses were performed to evaluate the intervention effect more specifically.ResultsFifteen trials with a total of 787 participants (394 subjects in the tDCS groups were treated with true tDCS, and 393 subjects in the control groups were wait-listed or treated with sham tDCS) involving tDCS for dysphagia after stroke and were included in the meta-analysis. Results of this meta-analysis confirmed that tDCS had a positive effect on post-stroke dysphagia. Subgroup analyses revealed that bilateral and high-intensity stimulation with tDCS had a more significant impact on post-stroke dysphagia. Furthermore, no adverse events occurred during the application of tDCS for post-stroke dysphagia.ConclusiontDCS can promote the recovery of deglutition function in patients with dysphagia after stroke. In addition, bilateral stimulation and high-intensity stimulation may have better effects. However, the safety evidence for tDCS and post-stroke dysphagia is insufficient.

Dataset Information

Fostering eating after stroke (FEASt) trial for improving post-stroke dysphagia with non-invasive brain stimulation.

Publications

Fostering eating after stroke (FEASt) trial for improving post-stroke dysphagia with non-invasive brain stimulation.

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