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

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Expiratory muscle strength training (EMST); Other: Transcranial magnetic stimulation (TMS)

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EMST and sham-TMS; Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation	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.
Other: sham-EMST and TMS; Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation	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.
Other: EMST and TMS; Active expiratory muscle strength training in combination with active transcranial magnetic stimulation	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.
Other: sham-EMST and sham-TMS; Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Deutsche Parkinson Vereinigung e.V. (dPV)
• Investigators: Principal Investigator: Tobias Warnecke, MD, University of Muenster

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): April 6, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD-EMST-TMS