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| Name | Class |
|---|---|
| Deutsche Parkinson Vereinigung | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMST and sham-TMS | Other | Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation |
|
| sham-EMST and TMS | Other | Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation |
|
| EMST and TMS | Other | Active expiratory muscle strength training in combination with active transcranial magnetic stimulation |
|
| sham-EMST and sham-TMS | Other | Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expiratory muscle strength training (EMST) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia severity as measured by FEES | Four weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Warnecke, MD | Universität Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, University Hospital of Muenster | Münster | North Rhine-Westphalia | D-48149 | Germany |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Transcranial magnetic stimulation (TMS) | Other | A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training. |
|
| Dysphagia severity as measured by FEES | Three month |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |