Parkinson's DiseaseNCT02461082
EMST and TMS for Treatment of Dysphagia in Parkinson's Disease
A study testing Expiratory muscle strength training (EMST) and Transcranial magnetic stimulation (TMS) in people with Parkinson's Disease, run by University Hospital Muenster at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Expiratory muscle strength training (EMST) and Transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn \& Yahr stages II-IV
- Parkinson-related dysphagia
- Oral nutrition
- Ambulant setting
- No change of medication for at least 4 weeks before study inclusion
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of neurology, University Hospital of Muenster
Münster, North Rhine-Westphalia, D-48149
About this study
Official title: Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders 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).
- Conditions
- Parkinson's Disease
- Being tested
- Expiratory muscle strength training (EMST), Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| EMST and sham-TMS | Other | Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation Receives: 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 Receives: 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 Receives: 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 Receives: Device: Expiratory muscle strength training (EMST); Other: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia severity as measured by FEES
Measured: Four weeks
Secondary outcomes (3)
Cortical reorganization of swallowing process as detected by MEG
Measured: Four weeks and three month
Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)
Measured: Four weeks and three months
Dysphagia severity as measured by FEES
Measured: Three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion6 Apr 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Parkinson Vereinigung
- Responsible party
- Sponsor
- Investigators
- Tobias Warnecke, MD, Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461082
- Sponsor's protocol ID
- PD-EMST-TMS
- Status last verified
- Oct 2017
- First submitted
- 27 May 2015
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02461082
- Acronym / sponsor ID
- PD-EMST-TMS
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Deutsche Parkinson Vereinigung
- Study start
- May 2015
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EMST and sham-TMS | Other | Device: Expiratory muscle strength training (EMST), Other: Transcranial magnetic stimulation (TMS)Active expiratory muscle strength training in combination with sham transcranial magnetic stimulation |
| sham-EMST and TMS | Other | Device: Expiratory muscle strength training (EMST), Other: Transcranial magnetic stimulation (TMS)Sham expiratory muscle strength training in combination with active transcranial magnetic stimulation |
| EMST and TMS | Other | Device: Expiratory muscle strength training (EMST), Other: Transcranial magnetic stimulation (TMS)Active expiratory muscle strength training in combination with active transcranial magnetic stimulation |
| sham-EMST and sham-TMS | Other | Device: Expiratory muscle strength training (EMST), Other: Transcranial magnetic stimulation (TMS)Sham expiratory muscle strength training in combination with sham transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hoehn \& Yahr stages II-IV
- Parkinson-related dysphagia
- Oral nutrition
- Ambulant setting
- No change of medication for at least 4 weeks before study inclusion
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | EMST and TMS, EMST and sham-TMS, sham-EMST and TMS, sham-EMST and sham-TMS |
| Transcranial magnetic stimulation (TMS)A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training. | Other | EMST and TMS, EMST and sham-TMS, sham-EMST and TMS, sham-EMST and sham-TMS |
Primary outcome
Dysphagia severity as measured by FEES
Time frame: Four weeks
3 secondary outcomes
Cortical reorganization of swallowing process as detected by MEG
Time frame: Four weeks and three month
Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)
Time frame: Four weeks and three months
Dysphagia severity as measured by FEES
Time frame: Three month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Warnecke, MD principal investigator
Universität Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle strength training (EMST) and Transcranial magnetic stimulation (TMS) in people with Parkinson's Disease, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia severity as measured by FEES (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.