Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2024-08-01
2025-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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5 Hz
Our patients in this arm will receive 10 sessions of treatment on the rTMS device. The device setting will be 5 Hz. All patients will also receive massako, shaker, triflo and cervical strengthening exercises. Our patients will be evaluated with FEES (Fiberoptic endoscopic swallowing evaluation) before, at the end of the treatment and at the 9th month controls in terms of the status of dysphagia.
Repetitive Transcranial Magnetic Stimulation
In our study, rTMS device was used to target the pharyngeal cortex for therapeutic purposes in patients with dysphagia diagnosed with Parkinson's disease. The most important point that distinguishes our study from other studies is that it aims to determine the effectiveness of rTMS treatment at high frequencies in the treatment of dysphagia. For this purpose, 5 Hz and 10 Hz treatments were applied to the patients from two different arms.
Exercise
In our study, patients in both arms were given shaker, massako, cervical strengthening and triflo exercises.
10 Hz
Our patients in this arm will receive 10 sessions of treatment on the rTMS device. The device setting will be 10 Hz. All patients will also receive massako, shaker, triflo and cervical strengthening exercises. Our patients will be evaluated with FEES (Fiberoptic endoscopic swallowing evaluation) before, at the end of the treatment and at the 9th month controls in terms of the status of dysphagia.
Repetitive Transcranial Magnetic Stimulation
In our study, rTMS device was used to target the pharyngeal cortex for therapeutic purposes in patients with dysphagia diagnosed with Parkinson's disease. The most important point that distinguishes our study from other studies is that it aims to determine the effectiveness of rTMS treatment at high frequencies in the treatment of dysphagia. For this purpose, 5 Hz and 10 Hz treatments were applied to the patients from two different arms.
Exercise
In our study, patients in both arms were given shaker, massako, cervical strengthening and triflo exercises.
Interventions
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Repetitive Transcranial Magnetic Stimulation
In our study, rTMS device was used to target the pharyngeal cortex for therapeutic purposes in patients with dysphagia diagnosed with Parkinson's disease. The most important point that distinguishes our study from other studies is that it aims to determine the effectiveness of rTMS treatment at high frequencies in the treatment of dysphagia. For this purpose, 5 Hz and 10 Hz treatments were applied to the patients from two different arms.
Exercise
In our study, patients in both arms were given shaker, massako, cervical strengthening and triflo exercises.
Eligibility Criteria
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Inclusion Criteria
* Moderate-to-severe Parkinson's disease (Hoehn yahr 2-4)
* The patient describing dysphagia symptoms
* Patients being able to give informed consent.
Exclusion Criteria
* Cardiac pace-maker
* History of seizure
* İntracranial lesion on imaging
* Hydrocephalus
* Antipsychotic use
* Babinski positivity
* Berebellar symptoms
* Depression
* Dementia
18 Years
75 Years
ALL
No
Sponsors
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Ege University
OTHER
Responsible Party
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Kübra Efe
Doctor
Principal Investigators
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Sibel Eyigor
Role: STUDY_DIRECTOR
Ege University Hospital
Locations
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Ege University Hospital
Izmir, Bornova, Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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E-70198063
Identifier Type: -
Identifier Source: org_study_id
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