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McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation

NCT ID: NCT06184711

Last Updated: 2023-12-28

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-29

Study Completion Date

2025-12-30

Brief Summary

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This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia.

Detailed Description

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Stroke is a neurological disorder that causes focal or global cerebral dysfunction caused by vascular causes, can last for 24 hours or longer, or may result in death. Many complications occur after stroke, and one of the most common complications is dysphagia After dysphagia, individuals with dehydration, malnutrition, aspiration, aspiration-related pneumonia, sepsis, and even death may result if no precautions are taken. Purpose of dysphagia treatment; It is to ensure that individuals receive their daily water and calorie needs most reliably. Another goal is to switch the patient to oral nutrition as much as possible. McNeill Dysphagia Therapy Programme is a systematic exercise-based therapy program developed for individuals with dysphagia. It is also frequently used in the rehabilitation of stroke, traumatic brain injury, and post-cancer dysphagia. Transcranial Magnetic Stimulation (TMS) is based on the principle of electromagnetic induction. It is a non-invasive method that, together with the magnetic field created by a coil placed on the scalp, causes electrical stimulation in the cerebral cortex and creates neurophysiological arrangements in different parts of the brain. Without the electrode, electrical energy is transferred to the human brain and the cerebral cortex is stimulated. An action potential is created by stimulation in neuronal membranes and causes neurons to fire. Thus, nerve cells are stimulated and the process of reorganization of the brain begins. With the stimulation of the cerebral cortex, the swallowing centre is stimulated and the muscles associated with swallowing are activated. The efficacy of MDTP combined with r TMS, MDTP combined with sham r TMS and r TMS alone will be compared in the intervention of dysphagia after stroke. Patients in all three groups will be subjected to both clinical assessment tools and instrumental evaluation before and after treatment. Data will be evaluated using the Mann Swallowing Ability Assessment Test, Penetration Aspiration Scale, Functional Oral Intake Scale, Visual Analogue Scale, Dynamic Rating Scale of Swallowing Toxicity, Dysphagia Severity Rating Scale

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme

The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme

Intervention Type DEVICE

The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.

Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme

The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.

Group Type SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme

Intervention Type DEVICE

The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.

Transcranial Magnetic Stimülation

Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.

Interventions

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Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme

The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.

Intervention Type DEVICE

Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme

The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.

Intervention Type DEVICE

Transcranial Magnetic Stimulation

Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Dysphagia Diagnosis of ischaemic stroke Over 18 years old Cognitively competent and co-operative

Exclusion Criteria

Epilepsy or seizure risk record Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Kübra Nur Şimşek

Speech and Language Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kübra Nur ŞİMŞEK

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Kübra Nur ŞİMŞEK

Role: CONTACT

Phone: +905543454446

Email: [email protected]

Other Identifiers

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AnkaraCHBilkentKNS

Identifier Type: -

Identifier Source: org_study_id