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Completed

NCT Number: NCT02461082

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

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of neurology, University Hospital of Muenster

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Transcranial magnetic stimulation (TMS)

Other

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

Primary outcomes

  1. Dysphagia severity as measured by FEES

    Time frame: Four weeks

Secondary outcomes

  1. Cortical reorganization of swallowing process as detected by MEG

    Time frame: Four weeks and three month

  2. Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)

    Time frame: Four weeks and three months

  3. Dysphagia severity as measured by FEES

    Time frame: Three month

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Deutsche Parkinson Vereinigung

Registry information

Official study title

Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders in Parkinson's Disease

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 3, 2015
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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