McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184711
• Other study ID #: AnkaraCHBilkentKNS
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 29, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: Ankara City Hospital Bilkent
• Contact: Kübra Nur SIMSEK
• Phone: +905543454446
• Email: kbranrsimsek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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