Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia
NCT ID: NCT05190718
Last Updated: 2025-03-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
100 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-12-15
Study Completion Date
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
NCT06827301
Dysphagia Following Cerebrovascular Accident
RECRUITING
NA
Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control : TENSVIRT Study
NCT02170506
Oropharyngeal Dysphagia
Deglutition Disorders
COMPLETED
NA
Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration
NCT00213343
Velopharyngeal Insufficiency
TERMINATED
Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism
NCT06386159
Post-extubation Dysphagia
RECRUITING
NA
The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function
NCT04682704
Atrial Fibrillation
Heart Failure, Diastolic
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. For example, dysphagia is found in 50% - 60% of all patients suffering a stroke or a traumatic brain injury. These patients are 4-times more likely to develop aspiration pneumonia and have a higher mortality rate. In patients with Parkinson's disease, pneumonia due to dysphagia is the most common cause of death. In addition, neurogenic dysphagia can have a significant impact on quality of life, medication efficacy, and malnutrition. Patients with neurogenic dysphagia, undergo standardized screening and, if indicated, a complementary dysphagia assessment as soon as possible to ensure the best possible care.
Dysphagia used to be treated conservatively with programmes of 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 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 multicentre based register study.
Objective:
The investigators aim to demonstrate 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 can be formulated as follows:
Does the use of the pharyngeal electrostimulation probe have an influence on the outcome of dysphagia in patients with moderate to severe neurogenic dysphagia? In what period of time after therapy can the use of the pharyngeal electrostimulation probe lead to oral food intake and/or removal of a tracheal cannula?
Study Design / Methodology:
The project will be carried out as a register study as part of a quality assurance project. All patients with moderate to severe neurogenic dysphagia, who show a potential for rehabilitation, will be included. The severity of dysphagia will first be classified with clinically validated screenings and scores. These tests include the Gugging Swallowing Screen (GUSS), the Dysphagia Severity Rating Scale (DSRS) and the Bogenhausen Dysphagia Score (BODS 1+2). The Fibreoptic Endoscopic Evaluation of Swallowing (FEES), the golden standard for dysphagia classification, is used as instrumental assessment. In the setting of these standardized tests, the investigators will perform the validated Penetration Aspiration Scale (PAS) and Secretion Severity Scale (SSS) to evaluate dysphagia severity. These data will be collected prior to stimulation therapy.
Pharyngeal stimulation therapy follows a standardised protocol. A special feeding tube (Phagenyx®) equipped with stimulation electrodes is placed in the stomach via the nasopharynx. It can be used for both therapy and nutrition and remains in the patient like a conventional feeding tube. The therapy is performed with a stimulation device connected to the nasogastric catheter. For cooperative patients an individual stimulation threshold (value in milliampere (mA)); stimulation threshold / tolerance limit) is determined. Based on 3 values for lower threshold and 3 values for upper threshold level the optimal stimulation value is calculated. The electrostimulation therapy takes place for a duration of 10 minutes at this value. In non-cooperative patients, a standardised 12 milliampere (mA) value is administered. A maximum of 6 treatments in total can be delivered to the patient after which point the catheter will be electronically locked to prevent further treatments from being delivered to the patient.
Treatment Regime and Rules:
The first treatment may take place from 2 hours post catheter insertion. The sessions should ideally take place on consecutive days but the interval must be no longer than 48 hours between completed sessions and no shorter than 14 hours. This is monitored and controlled by the Base Station software. There is no upper limit on the interval between the 3rd and 4th treatments to provide an opportunity for patient assessment. The software is designed to deliver electrical stimulus for 10 minutes in each session. The session may be manually paused by the operator if required or automatically by the Base Station if it detects an electrode contact problem. In either case, the treatment must be continued within 4 minutes of the pause initiation or else the session is classified as incomplete and must be repeated. In the event of an incomplete session, and if the patient agrees to continue with treatment, it is possible to attempt to retry a session up to 2 more times within that 14-hour period. The Base Station is designed to check the quality of contact for each pulse of stimulus delivered (5 pulses per second). In the event that contact quality falls below the acceptable level for a continuous period of 10 seconds then the software will alert the operator and automatically pause the session. This then provides an opportunity for the operator to adjust the position of the catheter or patient in order to restore contact. If the 48 hour interval between the treatments is unavoidably exceeded, then the treatment counter in the software is re-set and some treatments must be repeated. The counter is re-set to zero if the 48 hour interval is exceeded in between any of the first three treatments. The counter is re-set to 3 if the interval is exceeded after 3 treatments have already been delivered. Note: The 48 hour maximum interval does not apply between treatment 3 and 4 in order to allow the user to assess patient response to the standard three treatment sessions. In the event the 48 hour limit is unavoidably exceeded on multiple occasions due to problems (and the treatment counter re-set to zero more than once) as many as 9 complete treatments may theoretically be delivered. No more than 15 treatment sessions (made up of both complete and incomplete treatments) are allowed for a single patient.
Methodology:
This study is conducted in 3 phases. Phase 1: Neurological and dysphagic parameters are systematically assessed with the following routine examinations. The modified Ranking Scale (mRS), the NIHSS, as well as a Bedside swallowing screening procedure (GUSS) and scales and scores for food intake (DSRS, BODS 1+2) are collected.
Furthermore, the Golden Standard for swallowing diagnostics, the Fibreoptic Endoscopic Evaluation of Swallowing (FEES), is carried out to evaluate the swallowing pathology and classify its severity.
Phase 2: 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 depends on therapy progress (max 6 stimulations) and an interdisciplinary re-evaluation of the patient's rehabilitation potential. This allows for decision making regarding further rehabilitation steps. At the end of stimulation, the same parameters as before are measured.
Phase 3: takes place before the patient's discharge from hospital and includes a final re-examination using the same dysphagia and neurological parameters to document long-term effects.
Dysphagia used to be treated conservatively with programmes of 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 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 multicentre based register study.
Objective:
The investigators aim to demonstrate 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 can be formulated as follows:
Does the use of the pharyngeal electrostimulation probe have an influence on the outcome of dysphagia in patients with moderate to severe neurogenic dysphagia? In what period of time after therapy can the use of the pharyngeal electrostimulation probe lead to oral food intake and/or removal of a tracheal cannula?
Study Design / Methodology:
The project will be carried out as a register study as part of a quality assurance project. All patients with moderate to severe neurogenic dysphagia, who show a potential for rehabilitation, will be included. The severity of dysphagia will first be classified with clinically validated screenings and scores. These tests include the Gugging Swallowing Screen (GUSS), the Dysphagia Severity Rating Scale (DSRS) and the Bogenhausen Dysphagia Score (BODS 1+2). The Fibreoptic Endoscopic Evaluation of Swallowing (FEES), the golden standard for dysphagia classification, is used as instrumental assessment. In the setting of these standardized tests, the investigators will perform the validated Penetration Aspiration Scale (PAS) and Secretion Severity Scale (SSS) to evaluate dysphagia severity. These data will be collected prior to stimulation therapy.
Pharyngeal stimulation therapy follows a standardised protocol. A special feeding tube (Phagenyx®) equipped with stimulation electrodes is placed in the stomach via the nasopharynx. It can be used for both therapy and nutrition and remains in the patient like a conventional feeding tube. The therapy is performed with a stimulation device connected to the nasogastric catheter. For cooperative patients an individual stimulation threshold (value in milliampere (mA)); stimulation threshold / tolerance limit) is determined. Based on 3 values for lower threshold and 3 values for upper threshold level the optimal stimulation value is calculated. The electrostimulation therapy takes place for a duration of 10 minutes at this value. In non-cooperative patients, a standardised 12 milliampere (mA) value is administered. A maximum of 6 treatments in total can be delivered to the patient after which point the catheter will be electronically locked to prevent further treatments from being delivered to the patient.
Treatment Regime and Rules:
The first treatment may take place from 2 hours post catheter insertion. The sessions should ideally take place on consecutive days but the interval must be no longer than 48 hours between completed sessions and no shorter than 14 hours. This is monitored and controlled by the Base Station software. There is no upper limit on the interval between the 3rd and 4th treatments to provide an opportunity for patient assessment. The software is designed to deliver electrical stimulus for 10 minutes in each session. The session may be manually paused by the operator if required or automatically by the Base Station if it detects an electrode contact problem. In either case, the treatment must be continued within 4 minutes of the pause initiation or else the session is classified as incomplete and must be repeated. In the event of an incomplete session, and if the patient agrees to continue with treatment, it is possible to attempt to retry a session up to 2 more times within that 14-hour period. The Base Station is designed to check the quality of contact for each pulse of stimulus delivered (5 pulses per second). In the event that contact quality falls below the acceptable level for a continuous period of 10 seconds then the software will alert the operator and automatically pause the session. This then provides an opportunity for the operator to adjust the position of the catheter or patient in order to restore contact. If the 48 hour interval between the treatments is unavoidably exceeded, then the treatment counter in the software is re-set and some treatments must be repeated. The counter is re-set to zero if the 48 hour interval is exceeded in between any of the first three treatments. The counter is re-set to 3 if the interval is exceeded after 3 treatments have already been delivered. Note: The 48 hour maximum interval does not apply between treatment 3 and 4 in order to allow the user to assess patient response to the standard three treatment sessions. In the event the 48 hour limit is unavoidably exceeded on multiple occasions due to problems (and the treatment counter re-set to zero more than once) as many as 9 complete treatments may theoretically be delivered. No more than 15 treatment sessions (made up of both complete and incomplete treatments) are allowed for a single patient.
Methodology:
This study is conducted in 3 phases. Phase 1: Neurological and dysphagic parameters are systematically assessed with the following routine examinations. The modified Ranking Scale (mRS), the NIHSS, as well as a Bedside swallowing screening procedure (GUSS) and scales and scores for food intake (DSRS, BODS 1+2) are collected.
Furthermore, the Golden Standard for swallowing diagnostics, the Fibreoptic Endoscopic Evaluation of Swallowing (FEES), is carried out to evaluate the swallowing pathology and classify its severity.
Phase 2: 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 depends on therapy progress (max 6 stimulations) and an interdisciplinary re-evaluation of the patient's rehabilitation potential. This allows for decision making regarding further rehabilitation steps. At the end of stimulation, the same parameters as before are measured.
Phase 3: takes place before the patient's discharge from hospital and includes a final re-examination using the same dysphagia and neurological parameters to document long-term effects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Neurogenic Dysphagia
Traumatic Brain Injury
Stroke
Dysphagia
Long Covid-19
Intubation Complication
Polyradiculitis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dysphagia rehabilitation
All interventions are part of routine treatment of dysphagia.
Pharyngeal electrostimulation
Intervention Type
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pharyngeal electrostimulation
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.
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Phagenyx
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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).
* 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitätsklinikum Tulln
UNKNOWN
Sponsor Role
collaborator
Karl Landsteiner University of Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michaela Trapl-Grundschober
PhDr. Michaela Trapl-Grundschober, MSc, Departement of Clinical Neurology, Speech Therapist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Walter Struhal, Prof. Dr.
Role: STUDY_CHAIR
University Clinic Tulln
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Clinic Tulln
Tulln, Low Austria, Austria
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Austria
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
BARTOLOME, G.,& SCHRÖTER-MORASCH, H. H. 2006. Der Bogenhausener Dysphagiescore - BODS In: Schluckstörungen, München. Jena, Urban & Fischer Verlag.
Reference Type
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.
Reference Type
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.
Reference Type
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)
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SF21KTR500330021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator
NCT05483582
RECRUITING
NA
The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy
NCT03840395
RECRUITING
NA
Effect of Surface Electrical Stimulation on Movement of the Larynx
NCT00104000
COMPLETED
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
NCT03670485
COMPLETED
NA
The Safety and Efficacy of the 4 Channel NMES on Swallowing
NCT03670498
COMPLETED
NA
Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve
NCT02159586
ACTIVE_NOT_RECRUITING
Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis
NCT05405842
WITHDRAWN
NA
Vagus Nerve Response in Gastroparesis Patients
NCT04207996
ACTIVE_NOT_RECRUITING
The Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Oesophageal Pain Hypersensitivity
NCT02620176
UNKNOWN
NA
Transcutaneous Autonomic Modulation in Thoracic Surgery
NCT02783157
TERMINATED
NA
Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.
NCT06549205
COMPLETED
NA
Non-invasive Nervus Vagus Stimulation in Patients With COVID-19 and ARDS
NCT05058742
UNKNOWN
NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
NCT03603730
RECRUITING
NA
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Application on Respiratory Functions in Stroke Patients
NCT06793800
RECRUITING
NA
Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
NCT04028674
ACTIVE_NOT_RECRUITING
NA
Effect of Transauricular Vagal Stimulation on Cardiac Function After Spinal Cord Injury
NCT07007884
RECRUITING
NA
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
NCT01981590
COMPLETED
NA
ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
NCT06491758
RECRUITING
NA
Efficacy of Auricular Vagus Nerve Stimulation
NCT05586412
UNKNOWN
NA
Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure
NCT01252407
UNKNOWN
NA
The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain
NCT04503889
UNKNOWN
NA
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
NCT04668534
UNKNOWN
NA
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"
NCT04884698
COMPLETED
NA
Vagus Nerve Stimulation for Autonomic Nervous System Activity
NCT05906940
COMPLETED
NA
Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia
NCT06219343
RECRUITING
NA