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Effects of Pharyngeal Electrical Stimulation on Swallow Timings, Clearance and Safety in Post-Stroke Dysphagia: Analysis from the Swallowing Treatment Using Electrical Pharyngeal Stimulation (STEPS) Trial.

ABSTRACT: Swallowing impairment (dysphagia) post-stroke results in poorer outcomes. Pharyngeal electrical stimulation (PES) is a potential treatment for post-stroke dysphagia. In a post hoc analysis, we investigated PES using videofluoroscopy swallow studies (VFSS) from the STEPS trial incorporating multiple measures of safety (penetration aspiration scale-PAS), speed and duration (timing), and efficiency (clearance), as opposed to the original trial which only measured PAS scores. 81 randomised participants (PES (N = 43) versus sham (N = 38)) were analysed at baseline and 2 weeks. Participants swallowed up to 6 × 5 ml and 1 × 50 ml of thin liquid barium at 40% w/v, images at ≥25 fps. Based on PAS, the 5 ml mode bolus (most frequently occurring PAS from 6 × 5 ml) and the worst 50 ml bolus were chosen for further analysis. Eight timing measures were performed, including stage transition duration (STD) and pharyngeal transit time (PTT). Clearance measures comprised oral and pharyngeal residue and swallows to clear. Comparisons of change of scoring outcomes between PES and sham were done at 2 weeks. Wilcoxon Signed Ranks Test was also used to evaluate longitudinal changes from both groups' combined results at two weeks. Between-group analysis showed no statistically significant differences. Issues with suboptimal image quality and frame rate acquisition affected final numbers. At two weeks, both groups demonstrated a significant improvement in most safety scores (PAS) and STD, possibly due to spontaneous recovery or a combination of spontaneous recovery and swallowing treatment and usual care. A nonsignificant trend for improvement was seen in other timing measures, including PTT. This study, which conducted additional measurements of kinematic and residue analysis on the STEPS data did not detect "missed" improvements in swallowing function that the PAS is not designed to measure. However, more studies with greater numbers are required.

SUBMITTER: Everton LF

PROVIDER: S-EPMC8205591 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundNeurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia.MethodsThe PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia European Registry (PHADER) was a prospective single-arm observational cohort study. Participants were recruited with neurogenic dysphagia (comprising five groups - stroke not needing ventilation; stroke needing ventilation; ventilation acquired; traumatic brain injury; other neurological causes). PES was administered once daily for three days. The primary outcome was the validated dysphagia severity rating scale (DSRS, score best-worst 0-12) at 3 months.FindingsOf 255 enrolled patients from 14 centres in Austria, Germany and UK, 10 failed screening. At baseline, mean (standard deviation) or median [interquartile range]: age 68 (14) years, male 71%, DSRS 11·4 (1·7), time from onset to treatment 32 [44] days; age, time and DSRS differed between diagnostic groups. Insertion of PES catheters was successfully inserted in 239/245 (98%) participants, and was typically easy taking 11·8 min. 9 participants withdrew before the end of treatment. DSRS improved significantly in all dysphagia groups, difference in means (95% confidence intervals, CI) from 0 to 3 months: stroke (n = 79) -6·7 (-7·8, -5·5), ventilated stroke (n = 98) -6·5 (-7·6, -5·5); ventilation acquired (n = 35) -6·6 (-8·4, -4·8); traumatic brain injury (n = 24) -4·5 (-6·6, -2·4). The results for DSRS were mirrored for instrumentally assessed penetration aspiration scale scores. DSRS improved in both supratentorial and infratentorial stroke, with no difference between them (p = 0·32). In previously ventilated participants with tracheotomy, DSRS improved more in participants who could be decannulated (n = 66) -7·5 (-8·6, -6·5) versus not decannulated (n = 33) -2·1 (-3·2, -1·0) (p<0·001). 74 serious adverse events (SAE) occurred in 60 participants with pneumonia (9·2%) the most frequent SAE.InterpretationIn patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration.FundingPhagenesis Ltd.

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Effects of Pharyngeal Electrical Stimulation on Swallow Timings, Clearance and Safety in Post-Stroke Dysphagia: Analysis from the Swallowing Treatment Using Electrical Pharyngeal Stimulation (STEPS) Trial.

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