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

Study Overview
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Brief Summary
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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).

Official Title
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Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Expiratory muscle strength training (EMST)
* Other: Transcranial magnetic stimulation (TMS)


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EMST and sham-TMS<br>Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation | Device: Expiratory muscle strength training (EMST)<br>* 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).<br>Other: Transcranial magnetic stimulation (TMS)<br>* A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.<br>|
| Other: sham-EMST and TMS<br>Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation | Device: Expiratory muscle strength training (EMST)<br>* 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).<br>Other: Transcranial magnetic stimulation (TMS)<br>* A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.<br>|
| Other: EMST and TMS<br>Active expiratory muscle strength training in combination with active transcranial magnetic stimulation | Device: Expiratory muscle strength training (EMST)<br>* 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).<br>Other: Transcranial magnetic stimulation (TMS)<br>* A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.<br>|
| Other: sham-EMST and sham-TMS<br>Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation | Device: Expiratory muscle strength training (EMST)<br>* 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).<br>Other: Transcranial magnetic stimulation (TMS)<br>* A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia severity as measured by FEES |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical reorganization of swallowing process as detected by MEG |  | Four weeks and three month | 
| Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol) |  | Four weeks and three months | 
| Dysphagia severity as measured by FEES |  | Three month |