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Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

ABSTRACT: Background: Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia.

Methods: The 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.

Findings: Of 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.

Interpretation: In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration.

Funding: Phagenesis Ltd.

SUBMITTER: Bath PM

PROVIDER: S-EPMC7700977 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

Bath Philip M PM Woodhouse Lisa J LJ Suntrup-Krueger Sonja S Likar Rudolf R Koestenberger Markus M Warusevitane Anushka A Herzog Juergen J Schuttler Michael M Ragab Suzanne S Everton Lisa L Ledl Christian C Walther Ernst E Saltuari Leopold L Pucks-Faes Elke E Bocksrucker Christof C Vosko Milan M de Broux Johanna J Haase Claus G CG Raginis-Zborowska Alicja A Mistry Satish S Hamdy Shaheen S Dziewas Rainer R

EClinicalMedicine 20201110

<h4>Background</h4>Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia.<h4>Methods</h4>The 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; vent ...[more]

PMID: 33294818

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Project description:BackgroundHemiplegic Shoulder Pain (HSP) is among common complications occurring after stroke leading to disability. This study was conducted to compare the effects of electrical Interferential Current stimulation (IFC) and Electrical Acupuncture (EAC) on pain intensity, range of motion, and functional ability in patients with HSP and also comparing the two modalities regarding improvement of above indices.MethodsIn this randomized clinical trial, 46 patients with HSP caused by ischemic stroke were recruited and assigned into 2 groups. Conventional exercise trainings were applied for both groups. Group A received additional IFC with medium frequency of 4000 HZ, and Group B received additional EAC two times a week for a total of 10 sessions. Pain severity, daily function, and shoulder Range of Motion (ROM) were evaluated using Visual Analogue Scale (VAS), Shoulder Pain and Disability Index (SPADI), and goniometry, respectively before and 5 weeks after the treatment.ResultsBoth groups showed relative improvement in pain severity, SPADI score, and its subscales, and also active and passive shoulder ROM after the treatment. However, IFC group compared to EAC group had higher mean changes of active ROM in abduction (28.00 ± 3.81 vs. 12.25 ± 2.39) and functional subscale of SPADI (11.45 ± 1.88 vs. 5.80 ± 1.66) after the treatment. On the contrary, EAC group showed higher percentage of VAS changes (46.14 ± 6.88 vs. 34.28 ± 5.52), indicating better pain improvement compared to IFC group. Other parameters did not show significant difference between two groups.ConclusionBoth IFC and EAC caused short term improvement in functional state, increased motion, and decreased pain in patients with HSP. Although pain control was more evident in acupuncture group, IFC resulted in better effects on function and active ROM of abduction, and seems to have higher efficacy.Trial registrationThis clinical trial was registered in the Iranian Registry of Clinical Trials at 2016-07-16 with a registry number of IRCT201602153217N10.

Dataset Information

Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

Publications

Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

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