Evaluation of the Efficacy of a Two-week EMST on Dysphagia in Parkinsonian Patients
NCT ID: NCT05139342
Last Updated: 2023-06-15
Study Results
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.
UNKNOWN
NA
75 participants
INTERVENTIONAL
2021-11-15
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fatigue in Patients With Amyotrophic Lateral Sclerosis
NCT04468191
External Pharyngeal Exerciser and Dysphagia
NCT05708898
Tongue-strengthening Exercises in People With ALS.
NCT07295990
Effect of Functional Exercise in Patients With Spinal Bulbar Muscular Atrophy
NCT01369901
Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
NCT00001936
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Main hypothesis: Two weeks of EMST will lead to a significant improvement of the endoscopic dysphagia score in patients with neurodegenerative Parkinsonian disorders with endoscopically proven oropharyngeal dysphagia. Patients with idiopathic Parkinson's syndrome as well as its differential diagnoses, multiple system atrophy (MSA) and diseases from the group of 4repeat tauopathies, will be examined.
Idiopathic Parkinson's disease (PD):
More than 80% of all patients with PD develop clinically relevant dysphagia during the course of the disease. This can lead to a significant reduction in quality of life, decreased medication efficacy, malnutrition, dehydration, and ultimately aspiration pneumonia in affected patients, which is the most common cause of death in advanced PD patients. The cause of PD-associated dysphagia is a multifactorial genesis with impairment of dopaminergic and non-dopaminergic pathways of the central swallowing network and additional peripheral neuromuscular influences.
Multiple System Atrophy (MSA):
MSA is clinically associated with autonomic dysregulation manifested by neurogenic urinary bladder emptying dysfunction, orthostatic hypotension, sleep-related respiratory dysregulation, etc. in addition to Parkinsonian and/or cerebellar symptoms. Median survival after diagnosis is approximately 7 years. At disease onset, differentiation from idiopathic PD is difficult. However, relatively early in the course of the disease, symptoms such as a brittle voice or stridor may appear during normal breathing, which may be clues to the diagnosis of MSA. Since laryngeal abnormalities are associated with a significantly reduced life expectancy, they require special attention and diagnosis. In this regard, we have recently shown that a high prevalence of laryngeal movement abnormalities is present in MSA patients and can even be used to differentiate them from idiopathic Parkinson's disease. Swallowing function, the regulation of which is associated with autonomic centers of laryngeal function, is also often impaired early in patients with MSA. Because dysphagia can further limit quality of life and life expectancy, this symptom also requires early diagnosis and treatment. We could recently show that the dysphagia pattern also differs between PD and MSA.
4repeat tauopathies (4RT): The form of 4RT, also named progressive supranuclear gaze palsy (PSP) with all clinical subtypes, is a rapidly progressive neurodegenerative disease that leads to progressive functional impairment of cortical and subcortical function in affected individuals due to accumulation of tau protein in the brain. Due to the clinical variability of presentation, early diagnostic certainty is desirable, especially since human IgG4- antibodies directed against extracellular tau protein are currently in clinical trials to modify the course of the disease (see NCT03068468, NCT02985879). 4RT are also associated with swallowing and speech problems, and aspiration pneumonia is among the leading causes of death in this disease group. In addition, characteristic abnormalities may also occur due to dystonic dysinnervation of laryngeal muscles.
For dysphagia in atypical Parkinsonian syndromes, there are no proven interventional or drug therapy options. Previous studies in patients with PD had shown efficacy of a four-week training with a special expiratory muscle strength training (EMST) device. Both swallowing reliability and swallowing efficiency were improved. Studies on the efficacy of EMST on dysphagia of atypical Parkinsonian syndromes do not yet exist. Having demonstrated the efficacy of EMST in a 4-week intervention regime, the first aim is to test whether a shortened intervention duration of two weeks is also effective in patient with PD. In addition, this protocol will be performed in patients with MSA and 4RT to investigate effects, particularly on swallowing safety (reduction of penetration/aspiration events) and swallowing efficiency (reduction of pharyngeal residuals). Currently, all patients with PD, MSA, or 4RT at participating study sites receive a speech and language pathology examination and endoscopic diagnostics according to a defined protocol. In addition to phoniatric and swallowing-specific examinations, an endoscopic evaluation of swallowing (FEES) is routinely performed. Regarding the efficacy of EMST training on pharyngeal dysphagia in patients with PD, two randomized, placebo-controlled studies from recent years with n=60 and n=50 patients, respectively, have already shown an efficacy of training on both swallowing reliability and swallowing efficiency in PD patients. Relevant side effects or risks from training for the patients were not reported in the studies.
Studies using an EMST device have been conducted in recent years not only in patients with IPS, but also in patients with dysphagia due to other primary pathologies (e.g., amyotrophic lateral sclerosis, multiple sclerosis, stroke, etc.). In summary, a positive effect was shown, particularly on laryngeal muscle strengthening, which was reflected in an improvement in dysphagia.
The affected patients receive an initial endoscopic evaluation of the swallowing act in the clinical setting as part of routine diagnostics. In addition, oral and written patient education is provided. After written consent on the informed consent form, the following data are then collected anonymously prior to the start of the intervention:
1. sociographic data
2. disease milestones
3. MDS-UPDRS I-IV
4. UMSARS / PSP-RS
5. SDQ-PD
6. SWAL-QOL
7. Hoehn and Yahr stage
8. Current drug therapy
9. MSA-FEES examination protocol
10. Pulmonary function test
This is followed by the individual adjustment of the EMST device for the respective patient. For this purpose, the maximum expiratory pressure (MEP) is first determined for the respective patient in the pulmonary function examination using a pressure manometer. 75% of the MEP is set for the subsequent training on the EMST device. This is then followed by the actual intervention. For this, the patient receives logopedic instruction on the correct use of the EMST device. The intervention regime then consists of 5x5 breaths per day for 14 consecutive days. Immediately following, items 3-10 will be collected again.
1. The collection of data regarding the effectiveness of EMST in a shortened protocol (two weeks) on swallowing function in patients with PD can help to integrate this form of therapy firmly in the therapy regime of speech and language therapy also in the context of inpatient stays.
2. The evaluation of the efficacy of EMST in atypical Parkinsonian syndromes is the first interventional study with the attempt to improve dysphagia in these disease spectra. If this study demonstrates improvement in dysphagia in MSA and 4RT, appropriate patients would be offered a specific EMST in the future, which may then delay or prevent the development of higher-grade dysphagia. Since consecutive aspiration pneumonia on the floor of neurogenic dysphagia is the leading cause of death in these patients, this could at least delay serious medical complications in the future, improve quality of life, and prolong survival. In addition, new evidence would be gained for the use of activating therapies in the treatment of Parkinson's-associated dysphagia.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PD patients
patients diagnosed with PD will be allocated to this arm
expiratory muscle strentgh training (EMST)
All patients undergo EMST training, and results will be compared between groups.
After individual adjustment of the EMST device for each patient, the patient receives speeach adn instruction from a speech and language pathologist on the correct use of the EMST device. The intervention regime then consists of 5x5 breaths per day for 14 consecutive days.
MSA patients
patients diagnosed with MSAwill be allocated to this arm
expiratory muscle strentgh training (EMST)
All patients undergo EMST training, and results will be compared between groups.
After individual adjustment of the EMST device for each patient, the patient receives speeach adn instruction from a speech and language pathologist on the correct use of the EMST device. The intervention regime then consists of 5x5 breaths per day for 14 consecutive days.
4RT patients
patients diagnosed with 4RT will be allocated to this arm
expiratory muscle strentgh training (EMST)
All patients undergo EMST training, and results will be compared between groups.
After individual adjustment of the EMST device for each patient, the patient receives speeach adn instruction from a speech and language pathologist on the correct use of the EMST device. The intervention regime then consists of 5x5 breaths per day for 14 consecutive days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
expiratory muscle strentgh training (EMST)
All patients undergo EMST training, and results will be compared between groups.
After individual adjustment of the EMST device for each patient, the patient receives speeach adn instruction from a speech and language pathologist on the correct use of the EMST device. The intervention regime then consists of 5x5 breaths per day for 14 consecutive days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diagnosis of idiopathic Parkinson's disease according to the updated diagnostic criteria (Postuma 2015) or (3) Diagnosis of a possible or probable Multiple System Atrophy according to the diagnostic criteria (Gilman 2008) or (4) Diagnosis of a possible or probable progressive supranuclear gaze palsy according to the diagnostic criteria (Höglinger 2017) (5) in Hoehn and Yahr stages I-V.
Exclusion Criteria
2. Patients who have contraindications for a fiberendoscopic swallowing examination
3. Patients who have contraindications to the two weeks of EMST training (e.g., severe pulmonary disease, severe dementia).
4. Patients who have competing causes of dysphagia (e.g., history of stroke, tumor in the neck).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kliniken Beelitz GmbH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florin Gandor, MD
Role: PRINCIPAL_INVESTIGATOR
Movement Disorders Hospital Beelitz-Heilstätten,
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Movement Disorders Hospital - Kliniken Beelitz
Beelitz-Heilstätten, Brandenburg, Germany
Universitätsklinium Münster
Münster, , Germany
Klinikum Osnabrück
Osnabrück, , Germany
Countries
Review the countries where the study has at least one active or historical site.
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.
Claus I, Muhle P, Czechowski J, Ahring S, Labeit B, Suntrup-Krueger S, Wiendl H, Dziewas R, Warnecke T. Expiratory Muscle Strength Training for Therapy of Pharyngeal Dysphagia in Parkinson's Disease. Mov Disord. 2021 Aug;36(8):1815-1824. doi: 10.1002/mds.28552. Epub 2021 Mar 2.
Vogel A, Claus I, Ahring S, Gruber D, Haghikia A, Frank U, Dziewas R, Ebersbach G, Gandor F, Warnecke T. Endoscopic Characteristics of Dysphagia in Multiple System Atrophy Compared to Parkinson's Disease. Mov Disord. 2022 Mar;37(3):535-544. doi: 10.1002/mds.28854. Epub 2021 Nov 13.
Brooks M, McLaughlin E, Shields N. Expiratory muscle strength training improves swallowing and respiratory outcomes in people with dysphagia: A systematic review. Int J Speech Lang Pathol. 2019 Feb;21(1):89-100. doi: 10.1080/17549507.2017.1387285. Epub 2017 Nov 1.
Gandor F, Vogel A, Claus I, Ahring S, Gruber D, Heinze HJ, Dziewas R, Ebersbach G, Warnecke T. Laryngeal Movement Disorders in Multiple System Atrophy: A Diagnostic Biomarker? Mov Disord. 2020 Dec;35(12):2174-2183. doi: 10.1002/mds.28220. Epub 2020 Aug 5.
Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.
Hoglinger GU, Respondek G, Stamelou M, Kurz C, Josephs KA, Lang AE, Mollenhauer B, Muller U, Nilsson C, Whitwell JL, Arzberger T, Englund E, Gelpi E, Giese A, Irwin DJ, Meissner WG, Pantelyat A, Rajput A, van Swieten JC, Troakes C, Antonini A, Bhatia KP, Bordelon Y, Compta Y, Corvol JC, Colosimo C, Dickson DW, Dodel R, Ferguson L, Grossman M, Kassubek J, Krismer F, Levin J, Lorenzl S, Morris HR, Nestor P, Oertel WH, Poewe W, Rabinovici G, Rowe JB, Schellenberg GD, Seppi K, van Eimeren T, Wenning GK, Boxer AL, Golbe LI, Litvan I; Movement Disorder Society-endorsed PSP Study Group. Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria. Mov Disord. 2017 Jun;32(6):853-864. doi: 10.1002/mds.26987. Epub 2017 May 3.
Isono C, Hirano M, Sakamoto H, Ueno S, Kusunoki S, Nakamura Y. Differential Progression of Dysphagia in Heredity and Sporadic Ataxias Involving Multiple Systems. Eur Neurol. 2015;74(5-6):237-42. doi: 10.1159/000442252. Epub 2015 Dec 1.
Kalf JG, de Swart BJ, Bloem BR, Munneke M. Prevalence of oropharyngeal dysphagia in Parkinson's disease: a meta-analysis. Parkinsonism Relat Disord. 2012 May;18(4):311-5. doi: 10.1016/j.parkreldis.2011.11.006. Epub 2011 Dec 3.
Laciuga H, Rosenbek JC, Davenport PW, Sapienza CM. Functional outcomes associated with expiratory muscle strength training: narrative review. J Rehabil Res Dev. 2014;51(4):535-46. doi: 10.1682/JRRD.2013.03.0076.
Mancopes R, Smaoui S, Steele CM. Effects of Expiratory Muscle Strength Training on Videofluoroscopic Measures of Swallowing: A Systematic Review. Am J Speech Lang Pathol. 2020 Feb 7;29(1):335-356. doi: 10.1044/2019_AJSLP-19-00107. Epub 2020 Jan 30.
Miller N, Noble E, Jones D, Burn D. Hard to swallow: dysphagia in Parkinson's disease. Age Ageing. 2006 Nov;35(6):614-8. doi: 10.1093/ageing/afl105.
Muller J, Wenning GK, Verny M, McKee A, Chaudhuri KR, Jellinger K, Poewe W, Litvan I. Progression of dysarthria and dysphagia in postmortem-confirmed parkinsonian disorders. Arch Neurol. 2001 Feb;58(2):259-64. doi: 10.1001/archneur.58.2.259.
O'Sullivan SS, Massey LA, Williams DR, Silveira-Moriyama L, Kempster PA, Holton JL, Revesz T, Lees AJ. Clinical outcomes of progressive supranuclear palsy and multiple system atrophy. Brain. 2008 May;131(Pt 5):1362-72. doi: 10.1093/brain/awn065. Epub 2008 Apr 2.
Panegyres PK, Hillman D, Dunne JW. Laryngeal dystonia causing upper airway obstruction in progressive supranuclear palsy. J Clin Neurosci. 2007 Apr;14(4):380-1. doi: 10.1016/j.jocn.2005.12.019. Epub 2006 Apr 4.
Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
Silber MH, Levine S. Stridor and death in multiple system atrophy. Mov Disord. 2000 Jul;15(4):699-704. doi: 10.1002/1531-8257(200007)15:43.0.co;2-l.
Suttrup I, Warnecke T. Dysphagia in Parkinson's Disease. Dysphagia. 2016 Feb;31(1):24-32. doi: 10.1007/s00455-015-9671-9. Epub 2015 Nov 21.
Tilley E, McLoughlin J, Koblar SA, Doeltgen SH, Stern C, White S, Peters MD. Effectiveness of allied health therapy in the symptomatic management of progressive supranuclear palsy: a systematic review. JBI Database System Rev Implement Rep. 2016 Jun;14(6):148-95. doi: 10.11124/JBISRIR-2016-2002352.
Troche MS, Okun MS, Rosenbek JC, Musson N, Fernandez HH, Rodriguez R, Romrell J, Pitts T, Wheeler-Hegland KM, Sapienza CM. Aspiration and swallowing in Parkinson disease and rehabilitation with EMST: a randomized trial. Neurology. 2010 Nov 23;75(21):1912-9. doi: 10.1212/WNL.0b013e3181fef115.
Warnecke T, Suttrup I, Schroder JB, Osada N, Oelenberg S, Hamacher C, Suntrup S, Dziewas R. Levodopa responsiveness of dysphagia in advanced Parkinson's disease and reliability testing of the FEES-Levodopa-test. Parkinsonism Relat Disord. 2016 Jul;28:100-6. doi: 10.1016/j.parkreldis.2016.04.034. Epub 2016 Apr 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-2155-BO-ff
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.