Parkinson's Disease
Conditions
Brief 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).
Interventions
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.
Sponsors
Deutsche Parkinson Vereinigung
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysphagia severity as measured by FEES | Four weeks |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed