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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: Expiratory muscle strength training (EMST); Other: Transcranial magnetic stimulation (TMS)

• Registration Number: NCT02461082
• Lead Sponsor: University Hospital Muenster

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-03
• Status Verified: 2017-10
• Primary Completion: 2018-04-06
• Study Completion: 2018-08-28
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham-EMST and sham-TMS	Transcranial magnetic stimulation (TMS)	Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation
EMST and sham-TMS	Transcranial magnetic stimulation (TMS)	Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation
sham-EMST and TMS	Transcranial magnetic stimulation (TMS)	Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation
EMST and TMS	Expiratory muscle strength training (EMST)	Active expiratory muscle strength training in combination with active transcranial magnetic stimulation
sham-EMST and TMS	Expiratory muscle strength training (EMST)	Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation
EMST and sham-TMS	Expiratory muscle strength training (EMST)	Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation
EMST and TMS	Transcranial magnetic stimulation (TMS)	Active expiratory muscle strength training in combination with active transcranial magnetic stimulation
sham-EMST and sham-TMS	Expiratory muscle strength training (EMST)	Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation

Primary Outcome Measures

Name	Time	Method
Dysphagia severity as measured by FEES	Four weeks

Secondary Outcome Measures

Name	Time	Method
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
Cortical reorganization of swallowing process as detected by MEG	Four weeks and three month

Trial Locations

Locations (1)

Department of neurology, University Hospital of Muenster; 🇩🇪 Muenster, Nordrhein-Westfalen, Germany