McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation

Study Overview
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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

Official Title
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Efficiency of McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation in Individuals With Post-Stroke Dysphagia

Conditions
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Dysphagia

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme
* Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme
* Device: Transcranial Magnetic Stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme<br>The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group. | Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme<br>* The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.<br>|
| Sham Comparator: Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme<br>The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group. | Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme<br>* The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.<br>|
| Experimental: Transcranial Magnetic Stimülation<br>Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group. | Device: Transcranial Magnetic Stimulation<br>* Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration Aspiration Scale | Penetration Aspiration Scale (PAS): An 8-point severity rating. Scale 1 = no substance enters the airways 8 = substance enters the airways, passes under the vocal cords without any effort to expel it. | Change from baseline from 3 weeks | 
| Functional Oral Intake Scale | FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction) | Change from baseline from 3 weeks | 
| Dynamic Rating Scale of Swallowing Toxicity | Dynamic Imaging Grading of Ingestion Toxicity (DIGEST): residue less than 10% of the bolus = 0 point, residue less than half of the bolus = 1 point, residue less than 90% of the bolus = 2 points, residue more than 90% of the bolus = 3 points, residue in all consistencies tested = 4 points. | Change from baseline from 3 weeks | 
| Dysphagia Severity Scale | Dysphagia Severity Scale (DSS); those ranked from level 1 to level 4'' are categorized into the choking/aspiration group (severe group). In DSS, those ranked from level 5 to level 7'' are categorized into the without choking/aspiration group (mild group). | Change from baseline from 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mann Swallowing Ability Assessment Test | It is used for the assessment of oro-motor/sensory prerequisite skills of swallowing, functional assessment of swallowing and dietary modifications and identification of risk factors. A score of 138 and below indicates severe dysphagia, 139-167 indicates moderate dysphagia, 168-177 indicates mild dysphagia and 178-200 indicates no abnormality in swallowing. | Change from baseline from 3 weeks | 
| Visual Analogue Scale (VAS) | Visual Analogue Scale; Line bisection task or numerical grading.The patient 'marks' the point of current swallowing ability. He/she scores his/her swallowing from 1 to 10. - The patient 'marks' the point of current swallowing ability. He/she scores his/her swallowing from 1 to 10. | Change from baseline from 3 weeks |