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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Expiratory muscle strength training (EMST)
Transcranial magnetic stimulation (TMS)
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of neurology, University Hospital of Muenster

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

EMST and sham-TMS

sham-EMST and TMS

EMST and TMS

sham-EMST and sham-TMS

Arm Description

Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation

Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation

Active expiratory muscle strength training in combination with active transcranial magnetic stimulation

Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

Dysphagia severity as measured by FEES

Secondary Outcome Measures

Cortical reorganization of swallowing process as detected by MEG
Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)
Dysphagia severity as measured by FEES

Full Information

First Posted
May 27, 2015
Last Updated
September 21, 2018
Sponsor
University Hospital Muenster
Collaborators
Deutsche Parkinson Vereinigung e.V. (dPV)
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1. Study Identification

Unique Protocol Identification Number
NCT02461082
Brief Title
EMST and TMS for Treatment of Dysphagia in Parkinson's Disease
Official Title
Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 6, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
Collaborators
Deutsche Parkinson Vereinigung e.V. (dPV)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMST and sham-TMS
Arm Type
Other
Arm Description
Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation
Arm Title
sham-EMST and TMS
Arm Type
Other
Arm Description
Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation
Arm Title
EMST and TMS
Arm Type
Other
Arm Description
Active expiratory muscle strength training in combination with active transcranial magnetic stimulation
Arm Title
sham-EMST and sham-TMS
Arm Type
Other
Arm Description
Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
Expiratory muscle strength training (EMST)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.
Primary Outcome Measure Information:
Title
Dysphagia severity as measured by FEES
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Cortical reorganization of swallowing process as detected by MEG
Time Frame
Four weeks and three month
Title
Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)
Time Frame
Four weeks and three months
Title
Dysphagia severity as measured by FEES
Time Frame
Three month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Warnecke, MD
Organizational Affiliation
University of Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of neurology, University Hospital of Muenster
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
D-48149
Country
Germany

12. IPD Sharing Statement

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

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