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Completed

NCT Number: NCT07221110

rTMS Treatment of Dysphagia in Parkinson's Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Hospital

Izmir, Bornova, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • İntracranial metallic device
  • Cardiac pace-maker
  • History of seizure
  • İntracranial lesion on imaging
  • Hydrocephalus
  • Antipsychotic use
  • Babinski positivity
  • Berebellar symptoms
  • Depression
  • Dementia

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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

Other

In our study, patients in both arms were given shaker, massako, cervical strengthening and triflo exercises.

Primary outcomes

  1. 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

  2. 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.

  3. 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).

  4. 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).

  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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Effectiveness of Transcranial Magnetic Stimulation on Dysphagia in Patients With Parkinson's Disease: A Randomized Double-Blind Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2025
Registry last updated
Oct 27, 2025

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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