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McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation

A

Ankara City Hospital

Status

Not yet enrolling

Conditions

Dysphagia

Treatments

Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme
Device: Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme

Study type

Interventional

Funder types

Other

Identifiers

NCT06184711
AnkaraCHBilkentKNS

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme
Experimental group
Description:
The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.
Treatment:
Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme
Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme
Sham Comparator group
Description:
The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.
Treatment:
Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme
Transcranial Magnetic Stimülation
Experimental group
Description:
Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.
Treatment:
Device: Transcranial Magnetic Stimulation

Trial contacts and locations

1

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Central trial contact

Kübra Nur ŞİMŞEK

Data sourced from clinicaltrials.gov

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