rTMS Treatment of Dysphagia in Parkinson's Patients

NCT07221110 | Completed FDA Device

• 1 other identifier: E-70198063
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

rTMS; magnetic stimulation; Parkinson's disease; dysphagia

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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).

  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).

  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.

  until two weeks after the start of treatment

Study Arms (2)

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.

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.

Device: Repetitive Transcranial Magnetic Stimulation; Other: Exercise

Interventions

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.

10 Hz; 5 Hz

Exercise OTHER

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

10 Hz; 5 Hz

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Hospital

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Transcranial Magnetic Stimulation; Exercise

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sibel Eyigor

  Ege University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: there is no
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Our patients will receive treatment at different frequencies on the same rTMS device.

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 27, 2025
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 8, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)