Evaluation of the Efficacy of a Two-week EMST on Dysphagia in Parkinsonian Patients

NCT05139342 | Unknown

• 1 other identifier: 2021-2155-BO-ff
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

This is an interventional therapy study designed to evaluate the efficacy of a two-week intervention, i.e. training with a specialized exhalation training device (called expiratory muscle strength training; EMST150 or EMST75; Aspire Products, Gainsville, FL) on swallowing function in patients with neurodegenerative Parkinsonian disorders. This study involves a routine endoscopic evaluation of swallowing (FEES) to diagnose dysphagia before and after the intervention. Between the two FEES, a two-week exhalation training program takes place, which the patients perform independently following instructions from a speech and lanuage pathologist. In addition demographic and disease-specific data and two questionnaires (Swallowing Disturbance Questionnaire for Parkinson's disease patients, SDQ-PD, and Swallowing specific Quality Of Life Questionnaire SWAL-QoL) are recorded.

Conditions

Parkinson Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

Keywords

Parkinson's disease; Multiple System Atrophy; 4repeat tauopathies; dysphagia; EMST; FEES

Outcome Measures

Primary Outcomes (1)

• dysphagia-score

  improvement of dysphagia score observed on FEES after the intervention in all three groups. Three salient parameters of swallowing function are evaluated: 1. premature spillage 2. penetration-aspiration events 3. residue The scoring of these parameters is done separately using 3 ordinal 5-point scales (0- 4, from 0 = best to 4 = worst). Dysphagia severity, assessed by FEES, is classified according to a four-point scale (0-3) developed for patients with PD and atypical parkinsonism: 0 = no relevant dysphagia, 1. = mild dysphagia (premature spillage and/or residues without penetration/aspiration events), 2. = moderate dysphagia (penetration/aspiration events of one consistency), and 3. = severe dysphagia (penetration/aspiration events of two or more consistencies).

  14 days

Secondary Outcomes (2)

• SDQ-PD score

  14 days

• SWAL-QoL score

  14 days

Study Arms (3)

PD patients

ACTIVE COMPARATOR

patients diagnosed with PD will be allocated to this arm

Device: expiratory muscle strentgh training (EMST)

MSA patients

ACTIVE COMPARATOR

patients diagnosed with MSAwill be allocated to this arm

Device: expiratory muscle strentgh training (EMST)

4RT patients

ACTIVE COMPARATOR

patients diagnosed with 4RT will be allocated to this arm

Device: expiratory muscle strentgh training (EMST)

Interventions

expiratory muscle strentgh training (EMST) DEVICE

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; MSA patients; PD patients

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age with.
• 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.

You may not qualify if:

• Patients that do not sign the informed consent form
• Patients who have contraindications for a fiberendoscopic swallowing examination
• Patients who have contraindications to the two weeks of EMST training (e.g., severe pulmonary disease, severe dementia).
• Patients who have competing causes of dysphagia (e.g., history of stroke, tumor in the neck).

Sponsors & Collaborators

• Kliniken Beelitz GmbH: lead

Study Sites (3)

Movement Disorders Hospital - Kliniken Beelitz

Beelitz-Heilstätten, Brandenburg, 14547, Germany

RECRUITING

Universitätsklinium Münster

Münster, 48149, Germany

NOT YET RECRUITING

Klinikum Osnabrück

Osnabrück, 49076, Germany

RECRUITING

Related Publications (20)

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• 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.

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• 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.

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• 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.

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  PMID: 25144167 BACKGROUND

• 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.

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  PMID: 17047007 BACKGROUND

• 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.

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MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Deglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Florin Gandor, MD

  Movement Disorders Hospital Beelitz-Heilstätten,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florin Gandor, MD

CONTACT

+493320422781; gandor@kliniken-beelitz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: November 15, 2021
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after completion of data collection
• Access Criteria: Requests should be directed to the PI. Data will only be shared via individual secured network connections.

Locations

DE (3)