Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia

NCT05190718 | Recruiting

• 1 other identifier: SF21KTR500330021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Neurogenic dysphagia occurs with disruption of neurological systems or processes involved in the execution of coordinated and safe swallowing. It is common in patients with neurological diseases, in particular in patients treated in Intensive Care Units (ICU) who are intubated (up to 62%) and / or tracheotomised (up to 83%). Dysphagia is one of the most common and most dangerous symptoms of many neurological diseases. In addition, neurogenic dysphagia can have a significant impact on quality of life, medication efficacy, and malnutrition. Dysphagia is currently treated conservatively on evidence-based exercises, individually adapted to each patient. In the recent years pharyngeal electrostimulation has been established and shown a positive impact on outcome. In fact, this type of therapy has not only become an addition to the existing therapy, but an important alternative for patients difficult to treat by other means. The Phagenyx® is a medical device, which has lately been used more frequently in multiple hospitals for treatment of neurogenic dysphagia. For nearly two decades pharyngeal electrostimulation has been further developed and optimised. This therapy initiates changes in the swallowing motor cortex through neuroplasticity as well as local changes in peripheral sensory architecture associated with swallowing. Bath and colleagues (2020) recently reported the efficacy of pharyngeal electrostimulation (Phagenyx®) in various neurological conditions. As a result, of current published studies, the use of pharyngeal electrostimulation probe, in selected patients, with neurological diseases with moderate to severe neurogenic dysphagia will be evaluated. This trial will initially start as quality assurance project with the aim to extent it into a monocentric based register study. The Investigators aim to validate the effectiveness of pharyngeal electrostimulation for the treatment of moderate to severe neurogenic dysphagia by systematically recording specific dysphagia-relevant parameters. At present, it is still uncertain to what extent patients with neurogenic dysphagia in the context of a non-acute neurological disease could benefit from this method. The research questions: Does the use of the pharyngeal electrostimulation probe have an influence on the outcome of dysphagia in patients with moderate to severe neurogenic dysphagia? How long after therapy, can the use of the pharyngeal electrostimulation probe lead to oral food intake and/or removal of a tracheal cannula?

Conditions

Neurogenic Dysphagia; Traumatic Brain Injury; Stroke; Dysphagia; Long Covid-19; Intubation Complication; Polyradiculitis

Keywords

Neurogenic Dysphagia; Dysphagia; Traumatic Brain Injury; Phagenyx; Stroke; Pharyngeal electrical stimulation; Long Covid-19

Outcome Measures

Primary Outcomes (2)

• Dysphagia Severity Rating Scale (DSRS)

  The Dysphagia Severity Rating Scale (DSRS) describe the capacity of the patient to swallow food and fluids and if the patient needs help. The scale range from 0-12. 0= no dysphagia 12= severe dysphagia

  through study completion, an average of 1 year

• Penetration Aspiration Scale (PAS)

  Penetration Aspiration Scale (PAS) is measured during the Swallow endoscopy (FEES). The PAS is a measure of the penetration and aspiration of a bolus. In this study the investigators evaluate two semisolid and three liquid boluses. Scala ranges from 1-8. 1. Material does not enter the airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway 6. Material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject

  through study completion, an average of 1 year

Study Arms (1)

Dysphagia rehabilitation

All interventions are part of routine treatment of dysphagia.

Device: Pharyngeal electrostimulation

Interventions

Pharyngeal electrostimulation DEVICE

Routine treatment: Pharyngeal stimulation is performed via a nasogastric probe (Phagenyx) for a duration of 10 minutes daily and for at least 3 consecutive days. The number of stimulation repeats until max 2x3 repeats, depends on therapy progress and an interdisciplinary re-evaluation of the patient's rehabilitation potential.

Also known as: Phagenyx

Dysphagia rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neurogenic dysphagia

You may qualify if:

• Neurogenic dysphagia
• Ischaemic and haemorrhagic strokes
• Infra- as well as supra-tentorial
• Polyradiculitis
• Parkinson's disease
• Multiple sclerosis
• Dementia
• Traumatic brain injury
• Post Covid-19 pat.
• patients over the age of 18.

You may not qualify if:

• Contraindication to nasogastric tube,
• Unstable cardiac or respiratory condition that does not allow the insertion of the Nasogastric tube
• Pacemakers
• Implanted defibrillators (ICD)
• Pregnant
• Breastfeeding women
• (Caution: interfering signals may be visible in ECGs, \& EEGs with continuous recording).

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• Universitätsklinikum Tulln: collaborator

Study Sites (1)

University Clinic Tulln

Tulln, Low Austria, 3430, Austria

RECRUITING

Related Publications (16)

• Bath PM, Scutt P, Love J, Clave P, Cohen D, Dziewas R, Iversen HK, Ledl C, Ragab S, Soda H, Warusevitane A, Woisard V, Hamdy S; Swallowing Treatment Using Pharyngeal Electrical Stimulation (STEPS) Trial Investigators. Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial. Stroke. 2016 Jun;47(6):1562-70. doi: 10.1161/STROKEAHA.115.012455. Epub 2016 May 10.

  PMID: 27165955 BACKGROUND

• Bath PM, Woodhouse LJ, Suntrup-Krueger S, Likar R, Koestenberger M, Warusevitane A, Herzog J, Schuttler M, Ragab S, Everton L, Ledl C, Walther E, Saltuari L, Pucks-Faes E, Bocksrucker C, Vosko M, de Broux J, Haase CG, Raginis-Zborowska A, Mistry S, Hamdy S, Dziewas R; for PHADER Investigators. 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.

  PMID: 33294818 BACKGROUND

• Brodsky MB, Levy MJ, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Hillel AT, Best SR, Akst LM. Laryngeal Injury and Upper Airway Symptoms After Oral Endotracheal Intubation With Mechanical Ventilation During Critical Care: A Systematic Review. Crit Care Med. 2018 Dec;46(12):2010-2017. doi: 10.1097/CCM.0000000000003368.

  PMID: 30096101 BACKGROUND

• Brodsky MB, Nollet JL, Spronk PE, Gonzalez-Fernandez M. Prevalence, Pathophysiology, Diagnostic Modalities, and Treatment Options for Dysphagia in Critically Ill Patients. Am J Phys Med Rehabil. 2020 Dec;99(12):1164-1170. doi: 10.1097/PHM.0000000000001440.

  PMID: 32304381 BACKGROUND

• Dziewas R, Auf dem Brinke M, Birkmann U, Brauer G, Busch K, Cerra F, Damm-Lunau R, Dunkel J, Fellgiebel A, Garms E, Glahn J, Hagen S, Held S, Helfer C, Hiller M, Horn-Schenk C, Kley C, Lange N, Lapa S, Ledl C, Lindner-Pfleghar B, Mertl-Rotzer M, Muller M, Neugebauer H, Ozsucu D, Ohms M, Perniss M, Pfeilschifter W, Plass T, Roth C, Roukens R, Schmidt-Wilcke T, Schumann B, Schwarze J, Schweikert K, Stege H, Theuerkauf D, Thomas RS, Vahle U, Voigt N, Weber H, Werner CJ, Wirth R, Wittich I, Woldag H, Warnecke T. Safety and clinical impact of FEES - results of the FEES-registry. Neurol Res Pract. 2019 Apr 26;1:16. doi: 10.1186/s42466-019-0021-5. eCollection 2019.

  PMID: 33324882 BACKGROUND

• BARTOLOME, G.,& SCHRÖTER-MORASCH, H. H. 2006. Der Bogenhausener Dysphagiescore - BODS In: Schluckstörungen, München. Jena, Urban & Fischer Verlag.

  BACKGROUND

• Dziewas R, Glahn J, Helfer C, Ickenstein G, Keller J, Lapa S, Ledl C, Lindner-Pfleghar B, Nabavi D, Prosiegel M, Riecker A, Stanschus S, Warnecke T, Busse O. [FEES for neurogenic dysphagia: training curriculum of the German Society of Neurology and the German Stroke Society]. Nervenarzt. 2014 Aug;85(8):1006-15. doi: 10.1007/s00115-014-4114-7. German.

  PMID: 25060752 BACKGROUND

• Dziewas R, Mistry S, Hamdy S, Minnerup J, Van Der Tweel I, Schabitz W, Bath PM; PHAST-TRAC Investigators. Design and implementation of Pharyngeal electrical Stimulation for early de-cannulation in TRACheotomized (PHAST-TRAC) stroke patients with neurogenic dysphagia: a prospective randomized single-blinded interventional study. Int J Stroke. 2017 Jun;12(4):430-437. doi: 10.1177/1747493016676618. Epub 2016 Nov 2.

  PMID: 27807279 BACKGROUND

• Dziewas R., Pflug C. et al., Neurogene Dysphagie, S1-Leitlinie, 2020, in: Deutsche Gesellschaft für Neurologie (Hrsg.), Leitlinien für Diagnostik und Therapie in der Neurologie. Online: www.dgn.org/leitlinien (abgerufen am 02.07.2021)

  BACKGROUND

• Dziewas R, Stellato R, van der Tweel I, Walther E, Werner CJ, Braun T, Citerio G, Jandl M, Friedrichs M, Notzel K, Vosko MR, Mistry S, Hamdy S, McGowan S, Warnecke T, Zwittag P, Bath PM; PHAST-TRAC investigators. Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial. Lancet Neurol. 2018 Oct;17(10):849-859. doi: 10.1016/S1474-4422(18)30255-2. Epub 2018 Aug 28.

  PMID: 30170898 BACKGROUND

• Everton LF, Benfield JK, Hedstrom A, Wilkinson G, Michou E, England TJ, Dziewas R, Bath PM, Hamdy S. Psychometric assessment and validation of the dysphagia severity rating scale in stroke patients. Sci Rep. 2020 Apr 29;10(1):7268. doi: 10.1038/s41598-020-64208-9.

  PMID: 32350338 BACKGROUND

• Florea C, Braumann C, Mussger C, Leis S, Hauer L, Sellner J, Golaszewski SM. Therapy of Dysphagia by Prolonged Pharyngeal Electrical Stimulation (Phagenyx) in a Patient with Brainstem Infarction. Brain Sci. 2020 Apr 28;10(5):256. doi: 10.3390/brainsci10050256.

  PMID: 32353976 BACKGROUND

• Koestenberger M, Neuwersch S, Hoefner E, Breschan C, Weissmann H, Stettner H, Likar R. A Pilot Study of Pharyngeal Electrical Stimulation for Orally Intubated ICU Patients with Dysphagia. Neurocrit Care. 2020 Apr;32(2):532-538. doi: 10.1007/s12028-019-00780-x.

  PMID: 31313142 BACKGROUND

• Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

  PMID: 16269630 BACKGROUND

• Trapl M, Enderle P, Nowotny M, Teuschl Y, Matz K, Dachenhausen A, Brainin M. Dysphagia bedside screening for acute-stroke patients: the Gugging Swallowing Screen. Stroke. 2007 Nov;38(11):2948-52. doi: 10.1161/STROKEAHA.107.483933. Epub 2007 Sep 20.

  PMID: 17885261 BACKGROUND

• Warnecke T, Im S, Kaiser C, Hamacher C, Oelenberg S, Dziewas R. Aspiration and dysphagia screening in acute stroke - the Gugging Swallowing Screen revisited. Eur J Neurol. 2017 Apr;24(4):594-601. doi: 10.1111/ene.13251. Epub 2017 Feb 3.

  PMID: 28322006 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Deglutition Disorders; Post-Acute COVID-19 Syndrome; Polyradiculopathy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Walter Struhal, Prof. Dr.

  University Clinic Tulln

  STUDY CHAIR

Central Study Contacts

Michaela Trapl-Grundschober, MAS, MSc

CONTACT

+43 2272900422393; michaela.trapl@tulln.lknoe.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhDr. Michaela Trapl-Grundschober, MSc, Departement of Clinical Neurology, Speech Therapist

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: January 13, 2022
• Study Start: December 15, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

AU (1)