rTMS Treatment of Dysphagia in Parkinson's Patients

NCT ID: NCT07221110

Last Updated: 2025-10-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-10-08

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia Parkinson's Disease (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Our patients will receive treatment at different frequencies on the same rTMS device.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
there is no

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.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type 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

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type 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

Intervention Type OTHER

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.

Intervention Type DEVICE

Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Kübra Efe

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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E-70198063

Identifier Type: -

Identifier Source: org_study_id

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