Dataset Information

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:Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia. This is a randomized trial conducted in an inpatient rehabilitation facility. Thirty-one participants who had dysphagia caused by stroke within 6 months prior to enrolment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for modified barium swallow study (MBSS), or pre-morbid dysphagia. Each patient received ten sessions that included 45 min of anterior neck sensory or motor level electrical stimulation in addition to traditional dysphagia therapy. Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold at which the patient feels a tingling sensation on their skin. Swallow functional assessment measure (FAM), dysphagia outcome severity scale (DOSS), national outcome measurement system (NOMS), penetration aspiration scale (PAS), diet change, and the swallowing quality of life questionnaire (SWAL-QOL). Clinical outcomes were analyzed using a Wilcoxon signed-rank test, Mann-Whitney U test, RM ANOVA, or chi-square analysis. There was no significant difference in age, length of stay, or initial swallow FAM between groups. Patients in the sensory group showed significant improvement on swallow FAM, DOSS, and NOMS, while those in the motor group did not (Sensory: Swallow FAM (S = 48, p = 0.01), DOSS (S = 49.5, p = 0.001), NOMS (S = 52.5, p = 0.006); Motor: Swallow FAM (S = 20.5, p = 0.2), DOSS (S = 21, p = 0.05), NOMS (S = 29.5, p = 0.2)). When the groups were combined, there was statistically significant improvement on all measures except the PAS (Swallow FAM (S = 138.5, p = 0.003), DOSS (S = 134.5, p < 0.001), NOMS (S = 164, p = 0.0004)). When comparing motor to sensory NMES, there was no significant difference between groups for Swallow FAM (p = .12), DOSS (p = 0.52), or NOMS (p = 0.41). There was no significant difference in diet change for solid food or liquids among the groups, although 50% more participants in the sensory group saw improvement in diet. This study supports the use of electrical stimulation as part of the treatment plan for post-stroke dysphagia. Sensory-level stimulation was associated with greater improvement on outcome measures compared to motor level stimulation.

Project description:BackgroundPatients with amyotrophic lateral sclerosis (ALS) suffer from dysphagia that increases the risk for aspiration, pneumonia and weight loss. Pharyngeal electrical stimulation (PES) is a therapeutic technique that applies electric stimuli to the patient's pharynx in order to improve swallowing based on the principle of cortical plasticity and reorganization. Previous studies have demonstrated positive effects in patients with various neurological diseases.ObjectiveThis study was initiated to investigate the effect of PES on swallowing function in patients with ALS.MethodsIn all, 20 ALS patients with severe dysphagia [characterized by a Penetration Aspiration Scale (PAS) of at least 4 in thin liquid] were randomized to receive either PES for 10 min at 3 consecutive days in addition to Standard Logopaedic Therapy (SLT) or SLT alone. Swallowing function was evaluated by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) at five timepoints: at baseline, 1 day, 4 days, 3 weeks and 3 months after treatment. Primary endpoint was the severity of penetrations or aspirations as classified by PAS. Secondary endpoints were adverse events, dysphagia-related quality of life, Swallowing Quality of Life (SWAL-QOL), Dysphagia Severity Rating Scale (DSRS), residues, leaking, ALS Functional Rating Scale Revised (ALSFRS-R), and the performance in Clinical Evaluation of Swallowing (CES). The trial is registered under the name of 'Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis' with ClinialTrials.gov, number NCT03481348 (https://clinicaltrials.gov/ct2/show/NCT03481348).ResultsBoth groups combined showed a significant improvement (p = 0.003) of median Total-PAS from 3.6 [interquartile range (IQR) = 2.9-5.0] at baseline to 2.3 (IQR = 1.8-4.0) 1 day after treatment. During subsequent study visits, PAS increased again but remained below baseline. PES and control group did not differ significantly 1 day after intervention (p = 0.32). Similar effects were found in the majority of secondary endpoints.InterpretationThe findings suggest that PES may not provide an additional positive effect on swallowing function in ALS. SLT seems to yield at least short-term positive effects on swallowing function and swallowing-specific life quality in ALS.Registration: ClinialTrials.gov: NCT03481348.

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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