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

June 14, 2023 updated by: Kliniken Beelitz GmbH

Evaluation of the Efficacy of a Two-week Expiratory Muscle Training on Swallowing Function in Patients With Parkinsonian Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Münster, Germany, 48149
        • Not yet recruiting
        • Universitätsklinium Münster
        • Contact:
        • Sub-Investigator:
          • Tobias Warnecke, MD
      • Osnabrück, Germany, 49076
    • Brandenburg
      • Beelitz-Heilstätten, Brandenburg, Germany, 14547
        • Recruiting
        • Movement Disorders Hospital - Kliniken Beelitz
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Annemarie Vogel, M.Sc.
        • Sub-Investigator:
          • Georg Ebersbach, MD
        • Sub-Investigator:
          • Sykora Desiree, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  1. Patients that do not sign the informed consent form
  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PD patients
patients diagnosed with PD will be allocated to this arm
Device: 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.
Active Comparator: MSA patients
patients diagnosed with MSAwill be allocated to this arm
Device: 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.
Active Comparator: 4RT patients
patients diagnosed with 4RT will be allocated to this arm
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dysphagia-score
Time Frame: 14 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
SDQ-PD score
Time Frame: 14 days

improvement of SDQ-PD score after the intervention. SDQ comprises 15 items (score range 0.5 - 44.5 with higher scores indicating more severe swallowing disturbance) that are scored either 0 = symptom never appears,

  1. = appears seldom (≤1/month),
  2. = appears often (1-7/week),
  3. = appears very often (>7/week), item 15 was scored dichotomously: yes = 0.5
14 days
SWAL-QoL score
Time Frame: 14 days

improvement of SWAL_QoL score after the intervention

A 44item questionnaire (range 44 - 220) with lower scores indicating more severe impairment of swallowing-associated quality of life.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Beelitz GmbH

Investigators

  • Principal Investigator: Florin Gandor, MD, Movement Disorders Hospital Beelitz-Heilstätten,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2155-BO-ff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol, statistical analysis, informed consent form, and study data, including de-identified participant data, will be made available to others with publication upon formal request and receipt of a signed material transfer agreement. Requests should be directed to the corresponding author. Data will only be shared via individual secured network connections.

IPD Sharing Time Frame

after completion of data collection

IPD Sharing Access Criteria

Requests should be directed to the PI. Data will only be shared via individual secured network connections.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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