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CompletedNCT02461082Updated Sep 24, 2018

EMST and TMS for Treatment of Dysphagia in Parkinson's Disease

An interventional study of Expiratory muscle strength training (EMST) and Transcranial magnetic stimulation (TMS) in Parkinson's Disease, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-24.

Sponsored by University Hospital Muenster · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

The purpose of the study is to examine the effectiveness of different methods for the treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from PD develop dysphagia during the course of their disease leading to malnutrition, loss of life quality, weight loss and pneumonia, which is the leading cause of death in these patients. So far, only a few specific treatment approaches have been investigated in PD patients with swallowing disorders. The investigator want to compare a 4-week expiratory muscle strength training (EMST), transcranial magnetic stimulation (TMS), and combination of both with a sham therapy. Dysphagia severity before and after intervention is measured by flexible endoscopic evaluation of swallowing (FEES). For the evaluation of changes in cortical swallowing processing the investigators apply magnetoencephalography (MEG).

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Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 53 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hoehn \& Yahr stages II-IV
  • Parkinson-related dysphagia
  • Oral nutrition
  • Ambulant setting
  • No change of medication for at least 4 weeks before study inclusion

Exclusion criteria

Exclusion Criteria:

  • Other causes for dysphagia
  • Other neurological disease potentially causing dysphagia
  • Dementia (MMSE\<25; Montreal cognitive assessment (MoCA)\<26)
  • Severe depression (BDI>19)
  • Percutaneous endoscopic gastrostomy (PEG)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Other
    EMST and sham-TMS

    Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation

    Device: Expiratory muscle strength training (EMST) · Other: Transcranial magnetic stimulation (TMS)

  • Other
    sham-EMST and TMS

    Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation

    Device: Expiratory muscle strength training (EMST) · Other: Transcranial magnetic stimulation (TMS)

  • Other
    EMST and TMS

    Active expiratory muscle strength training in combination with active transcranial magnetic stimulation

    Device: Expiratory muscle strength training (EMST) · Other: Transcranial magnetic stimulation (TMS)

  • Other
    sham-EMST and sham-TMS

    Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation

    Device: Expiratory muscle strength training (EMST) · Other: Transcranial magnetic stimulation (TMS)

Interventions

  • DeviceExpiratory muscle strength training (EMST)

    The EMST is performed 4 weeks, 5 days per week, for 20 minutes per day, using a calibrated or sham, handheld device (EMST 150, Aspire Products, Gainesville, FL).

  • OtherTranscranial magnetic stimulation (TMS)

    A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

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What researchers measure

Primary outcomes

  1. Dysphagia severity as measured by FEES

    Time frame: Four weeks

Secondary outcomes

  1. Cortical reorganization of swallowing process as detected by MEG

    Time frame: Four weeks and three month

  2. Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)

    Time frame: Four weeks and three months

  3. Dysphagia severity as measured by FEES

    Time frame: Three month

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Study locations

1 site
  • Department of neurology, University Hospital of Muenster
    Muenster, Nordrhein-Westfalen D-48149, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02461082
Lead sponsor
University Hospital Muenster
Collaborators
Deutsche Parkinson Vereinigung
Responsible party
Sponsor
First posted
Jun 3, 2015
Start date
May 2015
Primary completion
Apr 6, 2018
Completion
Aug 28, 2018
Last update
Sep 24, 2018

Study contacts

Tobias Warnecke, MD
principal investigator · Universität Münster

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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