Clinical trial NCT06184711: McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation
Official title: Efficiency of McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation in Individuals With Post-Stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Change from baseline from 3 weeks
measure: Functional Oral Intake Scale
timeFrame: Change from baseline from 3 weeks
measure: Dynamic Rating Scale of Swallowing Toxicity
timeFrame: Change from baseline from 3 weeks
measure: Dysphagia Severity Scale
timeFrame: Change from baseline from 3 weeks
Secondary outcomes:
measure: Mann Swallowing Ability Assessment Test
timeFrame: Change from baseline from 3 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline from 3 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Kübra Nur ŞİMŞEK
role: PRINCIPAL_INVESTIGATOR
References: