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

NCT ID: NCT02461082

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-08-28

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).

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EMST and sham-TMS

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

Group Type: OTHER

Expiratory muscle strength training (EMST)

Intervention Type: DEVICE

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).

Transcranial magnetic stimulation (TMS)

Intervention Type: OTHER

A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

sham-EMST and TMS

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

Group Type: OTHER

Expiratory muscle strength training (EMST)

Intervention Type: DEVICE

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).

Transcranial magnetic stimulation (TMS)

Intervention Type: OTHER

A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

EMST and TMS

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

Group Type: OTHER

Expiratory muscle strength training (EMST)

Intervention Type: DEVICE

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).

Transcranial magnetic stimulation (TMS)

Intervention Type: OTHER

A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

sham-EMST and sham-TMS

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

Group Type: OTHER

Expiratory muscle strength training (EMST)

Intervention Type: DEVICE

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).

Transcranial magnetic stimulation (TMS)

Intervention Type: OTHER

A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

Interventions

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).

Intervention Type: DEVICE

Transcranial magnetic stimulation (TMS)

A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Parkinson Vereinigung

OTHER

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Warnecke, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Münster

Locations

Department of neurology, University Hospital of Muenster

Münster, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

PD-EMST-TMS

Identifier Type: -

Identifier Source: org_study_id