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

University Hospital Muenster

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Expiratory muscle strength training (EMST); Other: Transcranial magnetic stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02461082

PD-EMST-TMS

Details and patient eligibility

About

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).

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 4 patient groups

EMST and sham-TMS

Other group

Description:

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

Treatment:

Device: Expiratory muscle strength training (EMST)

Other: Transcranial magnetic stimulation (TMS)

sham-EMST and TMS

Other group

Description:

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

Treatment:

Device: Expiratory muscle strength training (EMST)

Other: Transcranial magnetic stimulation (TMS)

EMST and TMS

Other group

Description:

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

Treatment:

Device: Expiratory muscle strength training (EMST)

Other: Transcranial magnetic stimulation (TMS)

sham-EMST and sham-TMS

Other group

Description:

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

Treatment:

Device: Expiratory muscle strength training (EMST)

Other: Transcranial magnetic stimulation (TMS)