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

NCT02461082 | Completed

• 1 other identifier: PD-EMST-TMS
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Dysphagia severity as measured by FEES

  Four weeks

Secondary Outcomes (3)

• 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

Study Arms (4)

EMST and sham-TMS

OTHER

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

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

sham-EMST and TMS

OTHER

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

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

EMST and TMS

OTHER

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

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

sham-EMST and sham-TMS

OTHER

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

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

Interventions

Expiratory muscle strength training (EMST) 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).

EMST and TMS; EMST and sham-TMS; sham-EMST and TMS; sham-EMST and sham-TMS

Transcranial magnetic stimulation (TMS) OTHER

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

EMST and TMS; EMST and sham-TMS; sham-EMST and TMS; sham-EMST and sham-TMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hoehn \& Yahr stages II-IV
• Parkinson-related dysphagia
• Oral nutrition
• Ambulant setting

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Muenster: lead
• Deutsche Parkinson Vereinigung: collaborator

Study Sites (1)

Department of neurology, University Hospital of Muenster

Münster, North Rhine-Westphalia, D-48149, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Tobias Warnecke, MD

  Universität Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 3, 2015
• Study Start: May 1, 2015
• Primary Completion: April 6, 2018
• Study Completion: August 28, 2018
• Last Updated: September 24, 2018

Record last verified: 2017-10

Locations

DE (1)