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

Philip M Bath; Lisa J Woodhouse; Sonja Suntrup-Krueger; Rudolf Likar; Markus Koestenberger; Anushka Warusevitane; Juergen Herzog; Michael Schuttler; Suzanne Ragab; Lisa Everton; Christian Ledl; Ernst Walther; Leopold Saltuari; Elke Pucks-Faes; Christof Bocksrucker; Milan Vosko; Johanna de Broux; Claus G Haase; Alicja Raginis-Zborowska; Satish Mistry; Shaheen Hamdy; Rainer Dziewas; for PHADER Investigators

doi:10.1016/j.eclinm.2020.100608

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

EClinicalMedicine. 2020 Nov 10:28:100608. doi: 10.1016/j.eclinm.2020.100608. eCollection 2020 Nov.

Authors

Philip M Bath^{1

2}, Lisa J Woodhouse¹, Sonja Suntrup-Krueger³, Rudolf Likar⁴, Markus Koestenberger⁴, Anushka Warusevitane⁵, Juergen Herzog⁶, Michael Schuttler⁷, Suzanne Ragab⁸, Lisa Everton^{1

9}, Christian Ledl¹⁰, Ernst Walther¹¹, Leopold Saltuari¹², Elke Pucks-Faes¹², Christof Bocksrucker¹³, Milan Vosko¹⁴, Johanna de Broux¹⁵, Claus G Haase¹⁶, Alicja Raginis-Zborowska¹⁷, Satish Mistry¹⁷, Shaheen Hamdy^{17

18}, Rainer Dziewas³; for PHADER Investigators

Affiliations

¹ Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham NG5 1PB, United Kingdom.
² Stroke, Nottingham University Hospital NHS Trust, Nottingham NG5 1PB, United Kingdom.
³ Department of Neurology, University Hospital Münster, Building A1, Albert-Schweitzer-Campus 1, 48149 Münster, Germany.
⁴ Department of Anaesthesiology and Intensive Care Medicine, Klinikum Klagenfurt am Wörthersee, Klagenfurt am Wörthersee, Austria.
⁵ Stroke Research, Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Parish Building, 1st Floor, Newcastle Road, Stoke-on-Trent, Staffordshire ST4 6QG, United Kingdom.
⁶ Clinic for Neurological Rehabilitation and Early Rehabilitation, Schön Klinik München-Schwabing, Parzivalplatz 4, 80804 Munich, Germany.
⁷ Centre of Neurology, Schön Klinik Bad Staffelstein, Am Kurpark 11, 96231 Bad Staffelstein, Germany.
⁸ Department of Stroke, Philip Arnold Unit Ground Floor, Poole Hospital NHS Foundation Trust, Longfleet road, Poole BH15 2JB, United Kingdom.
⁹ Speech and Language Therapy, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham NG3 6AA, United Kingdom.
¹⁰ Specialist Clinic for Neurology, Neurological Rehabilitation and Alzheimer's Therapy, Schön Klinik Bad Aibling, Kolbermoorer Strasse 72, 83043 Bad Aibling, Germany.
¹¹ Clinic for Neurology and Neurorehabilitation, Schön Klinik Hamburg Eilbek, Hamburg, Germany.
¹² Department of Neurology, Ö. Landeskrankenhaus Hochzirl-Natters, Tiroler landesrankenanstalten GmbH. LkH Hochzirl, 6170 Zirl/Hochzirl, Austria.
¹³ Department of Neurology, Konventhospital Barmherzige Brúder Linz, Seilerstätte 2, 4021 Linz, Austria.
¹⁴ Department of Neurology 2, Kepler Universitätsklinikum, Med Campus III, Krankenhausstrasse 9, 4020 Linz, Austria.
¹⁵ Clinic for Neurology, Alexianer Krefeld GmbH, Dießemer Bruch 81, 47805 Krefeld, Germany.
¹⁶ Clinic for Neurology and Neurophysiology, Evangelische Kliniken Gelsenkirchen, Lehrkrankenhaus der Universität Essen-Duisburg, Munckelstr. 27, 45879 Gelsenkirchen, Germany.
¹⁷ Department for Clinical Research, Phagenesis Limited, Manchester M15 6SE, United Kingdom.
¹⁸ Centre for Gastrointestinal Sciences, Faculty of Biology, Medicine and Health, University of Manchester and the Manchester Academic Health Sciences Centre, Manchester M6 8HD, United Kingdom.

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.

Keywords: Decannulation; Dysphagia; Pharyngeal electrical stimulation; Stroke; Traumatic brain injury; Ventilation.