DysphagiaNCT07221110
rTMS Treatment of Dysphagia in Parkinson's Patients
A study testing Repetitive Transcranial Magnetic Stimulation and Exercise in people with Dysphagia and Parkinson's Disease (PD), run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted with patients with dysphagia who were followed up with Parkinson's disease in the neurology and physical therapy rehabilitation departments. The study is a prospective, double-blind clinical intervention study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dysphagia, Parkinson's Disease (PD)
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 8 Oct 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease for more than two years
- Moderate-to-severe Parkinson's disease (Hoehn yahr 2-4)
- The patient describing dysphagia symptoms
- Patients being able to give informed consent.
Who cannot join
- İntracranial metallic device
- Cardiac pace-maker
- History of seizure
- İntracranial lesion on imaging
- Hydrocephalus
- Antipsychotic use
Show all 10Show fewer
- Babinski positivity
- Berebellar symptoms
- Depression
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Transcranial Magnetic Stimulation on Dysphagia in Patients With Parkinson's Disease: A Randomized Double-Blind Study
The study was conducted with patients with dysphagia who were followed up with Parkinson's disease in the neurology and physical therapy rehabilitation departments. The study is a prospective, double-blind clinical intervention study. Patients were divided into two groups (5 Hz and 10 Hz) and received rTMS (repetitive transcranial magnetic stimulation) treatment. The pharyngeal cortex region was targeted in the intervention. Major aim in the treatment was to examine the difference in clinical response caused by the application of rTMS treatment at different frequencies.
- Conditions
- Dysphagia, Parkinson's Disease (PD)
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Exercise
- Keywords
- rTMS, magnetic stimulation, Parkinson's disease, dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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.
ExerciseOther
In our study, patients in both arms were given shaker, massako, cervical strengthening and triflo exercises.
| Study group | Role | What they receive |
|---|---|---|
| 5 Hz | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Other: Exercise |
| 10 Hz | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEES evaluation
For the evaluation, a thin flexible nasopharyngoscope was passed through the nasal passage to visualize the pharynx and larynx. Food trials were performed for the swallowing assessment. For this purpose, patients were given water, nectar in volumes of 3-5-10-20 ml; 1 teaspoon (5 ml) of yogurt and 1 fish cracker. After the evaluation, early spillage, penetration, aspiration, and the presence/absence of residue in the pharyngeal wall/retrocricoid area/piriform sinus/vallekula were recorded. At the same time, the YALE-2016 vallekular residue scale, YALE-2016 piriform sinus residue scale, and penetration aspiration scale (PAS) scores were determined.
YALE-2016 Vallekular/Piriform Sinus Residue Scale: This scale scores patients from 1 to 5 during flexible endoscopic examination based on the amount of residue in the vallekula and piriform sinus: none/trace/mild/moderate/severe.
PAS: This scale rates patients from 1to5 based on aspiration/penetration and the presence of a protective reflex
Measured: until two weeks after the start of treatment
Swallowing Assessment Form:
The form records data on patients' age, gender, duration of Parkinson's disease, duration of dysphagia, history of pneumonia, Hoehn-Yahr stage, type of nutrition, dysphagia with solid food, dysphagia with semi-solid food, dysphagia with liquid food, sensation of food getting stuck in the throat, sensation of choking, and need to clear the throat.
Measured: up to two weeks after the start of treatment
Functional Oral Intake Scale (FOIS):
Oral intake in patients; no oral intake (1), minimal attempt at solid-liquid food, dependent on tube feeding (2), continuous solid and liquid oral intake, but dependent on tube feeding (3), total oral diet of uniform consistency (4), total oral diet of varying consistencies, but requiring special preparation or compensation (5), total oral diet of varying consistencies, not requiring special preparation, but with specific food limitations (6), total oral diet without restrictions (7).
Measured: until two weeks after the start of treatment
Functional Swallowing Scale (FSS):
This scale assesses patients' daily dysphagia symptoms and associated weight loss. Patients are classified as normal function and asymptomatic (0), normal function with episodic or daily dysphagia symptoms (1), abnormal function compensated by significant dietary modifications (2), and abnormal function with decompensation, with <10% weight loss in the last 6 months due to dysphagia or coughing/ choking/aspiration during daily meals (3), severe decompensated abnormal function with >10% weight loss in the last 6 months due to dysphagia/severe aspiration/non-oral feeding for most foods (4), non-oral feeding for all foods (5).
Measured: until two weeks after the start of treatment
Swallowing Function Screening Test (EAT-10):
An EAT-10 score of 3 or higher indicates abnormality. This test can be used to determine the initial severity of dysphagia in individuals with various swallowing disorders or to monitor treatment response.
Measured: until two weeks after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start1 Aug 2024
- Primary completion1 Aug 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Model description
- Our patients will receive treatment at different frequencies on the same rTMS device.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Efe, Ege University
- Investigators
- Sibel Eyigor, Study director, Ege University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221110
- Sponsor's protocol ID
- E-70198063
- Status last verified
- Sep 2025
- First submitted
- 22 Oct 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: For the purpose of protecting personal data, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Magnetic Stimulation on Dysphagia in Patients With Parkinson's Disease: A Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT07221110
- Acronym / sponsor ID
- E-70198063
- Conditions
- Dysphagia, Parkinson's Disease (PD)
- Keywords
- rTMS, magnetic stimulation, Parkinson&#39;s disease, dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 27 Oct 2025 (actual)
- 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 study was conducted with patients with dysphagia who were followed up with Parkinson's disease in the neurology and physical therapy rehabilitation departments. The study is a prospective, double-blind clinical intervention study. Patients were divided into two groups (5 Hz and 10 Hz) and received rTMS (repetitive transcranial magnetic stimulation) treatment. The pharyngeal cortex region was targeted in the intervention. Major aim in the treatment was to examine the difference in clinical response caused by the application of rTMS treatment at different frequencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Our patients will receive treatment at different frequencies on the same rTMS device.
| Arm | Type | Receives |
|---|---|---|
| 5 Hz | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Other: ExerciseOur 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. |
| 10 Hz | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Other: ExerciseOur 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's disease for more than two years
- Moderate-to-severe Parkinson's disease (Hoehn yahr 2-4)
- The patient describing dysphagia symptoms
- Patients being able to give informed consent.
Key exclusion criteria (10 listed)
- İntracranial metallic device
- Cardiac pace-maker
- History of seizure
- İntracranial lesion on imaging
- Hydrocephalus
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationIn 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. | Device | 10 Hz, 5 Hz |
| ExerciseIn our study, patients in both arms were given shaker, massako, cervical strengthening and triflo exercises. | Other | 10 Hz, 5 Hz |
Primary outcome
FEES evaluation
Time frame: until two weeks after the start of treatment
For the evaluation, a thin flexible nasopharyngoscope was passed through the nasal passage to visualize the pharynx and larynx. Food trials were performed for the swallowing assessment. For this purpose, patients were given water, nectar in volumes of 3-5-10-20 ml; 1 teaspoon (5 ml) of yogurt and 1 fish cracker. After the evaluation, early spillage, penetration, aspiration, and the presence/absence of residue in the pharyngeal wall/retrocricoid area/piriform sinus/vallekula were recorded. At the same time, the YALE-2016 vallekular residue scale, YALE-2016 piriform sinus residue scale, and penetration aspiration scale (PAS) scores were determined. YALE-2016 Vallekular/Piriform Sinus Residue Scale: This scale scores patients from 1 to 5 during flexible endoscopic examination based on the amount of residue in the vallekula and piriform sinus: none/trace/mild/moderate/severe. PAS: This scale rates patients from 1to5 based on aspiration/penetration and the presence of a protective reflex
Swallowing Assessment Form:
Time frame: up to two weeks after the start of treatment
The form records data on patients' age, gender, duration of Parkinson's disease, duration of dysphagia, history of pneumonia, Hoehn-Yahr stage, type of nutrition, dysphagia with solid food, dysphagia with semi-solid food, dysphagia with liquid food, sensation of food getting stuck in the throat, sensation of choking, and need to clear the throat.
Functional Oral Intake Scale (FOIS):
Time frame: until two weeks after the start of treatment
Oral intake in patients; no oral intake (1), minimal attempt at solid-liquid food, dependent on tube feeding (2), continuous solid and liquid oral intake, but dependent on tube feeding (3), total oral diet of uniform consistency (4), total oral diet of varying consistencies, but requiring special preparation or compensation (5), total oral diet of varying consistencies, not requiring special preparation, but with specific food limitations (6), total oral diet without restrictions (7).
Functional Swallowing Scale (FSS):
Time frame: until two weeks after the start of treatment
This scale assesses patients' daily dysphagia symptoms and associated weight loss. Patients are classified as normal function and asymptomatic (0), normal function with episodic or daily dysphagia symptoms (1), abnormal function compensated by significant dietary modifications (2), and abnormal function with decompensation, with <10% weight loss in the last 6 months due to dysphagia or coughing/ choking/aspiration during daily meals (3), severe decompensated abnormal function with >10% weight loss in the last 6 months due to dysphagia/severe aspiration/non-oral feeding for most foods (4), non-oral feeding for all foods (5).
Swallowing Function Screening Test (EAT-10):
Time frame: until two weeks after the start of treatment
An EAT-10 score of 3 or higher indicates abnormality. This test can be used to determine the initial severity of dysphagia in individuals with various swallowing disorders or to monitor treatment response.
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 27 Oct 2025.
- Individual participant dataSharing planned: No. For the purpose of protecting personal data, individual participant data will not be shared.
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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.
Sibel Eyigor study director
Ege University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Exercise in people with Dysphagia and Parkinson's Disease (PD), run by Ege University at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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 27 Oct 2025. 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 Turkey (Türkiye). 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?
FEES evaluation (time frame: until two weeks after the start of treatment). The study lists 5 primary outcomes in all. 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 27 Oct 2025.