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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461082
• Other study ID #: PD-EMST-TMS
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: August 28, 2018

Study information

• Verified date: October 2017
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 28, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Expiratory 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).

Other:
• Transcranial magnetic stimulation (TMS)
A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

Locations

Country	Name	City	State
Germany	Department of neurology, University Hospital of Muenster	Muenster	Nordrhein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Deutsche Parkinson Vereinigung e.V. (dPV)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia severity as measured by FEES		Four weeks
Secondary	Cortical reorganization of swallowing process as detected by MEG		Four weeks and three month
Secondary	Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)		Four weeks and three months
Secondary	Dysphagia severity as measured by FEES		Three month