Prevalence of Pneumonia After Adding Repetitive Transcranial Magnetic Stimulation in Poststroke Dysphagia

Study Overview
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Brief Summary
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BACKGROUND: Dysphagia is one of the most life-threatening stroke complications. Dysphagic stroke patients are at increased risk of aspiration pneumonia. Pneumonia accounts for at least 10% of post stroke deaths within 30 days of hospitalization after stroke. rTMS is effective in improving post-stroke dysphagia and swallowing coordination after stimulation of the unaffected hemisphere, however it's efficacy on the prevalence of pneumonia has not yet been examined. Purpose of the study: To determine the effect of adding repetitive transcranial magnetic stimulation to conventional oropharyngeal physical therapy program on the prevalence of aspiration pneumonia in in patients with post stroke dysphagia.

Detailed Description
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Thirty Five acute ischemic stroke patients with oropharyngeal dysphagia from both sexes represented the sample of this study. They were diagnosed by a neurologist and stroke diagnosis was confirmed by brain MRI and/or CT. They were selected from the stroke unit El Kasr El Ainy hospital, Cairo university. They were randomly assigned into two equal groups, the control group (A) and the study group (B). Control group (GA) will be treated using a designed physical therapy intervention for oropharyngeal dysphagia consists of neuromuscular electrical stimulation combined with physical therapeutic exercise for oropharyngeal muscles in addition to sham repetitive transcranial magnetic stimulation. Study group (GB) will be treated with low frequency (1 Hz) rTMS to the contralesional cerebral hemisphere in addition to the same Oropharyngeal physical therapy program for dysphagia as in group A. Stroke dysphagia was diagnosed by a neurologist. The Gugging swallowing screen (GUSS) bedside screening test will be used to detect dysphagia and aspiration risk. A2DS2 scale is used to detect stroke associated pneumonia (SAP). Stroke associated pneumonia (SAP) will be diagnosed according to the criteria of the modified Center for Disease Control and Prevention (CDC).

Official Title
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Prevalence of Pneumonia After Adding Repetitive Transcranial Magnetic Stimulation to Conventional Oropharyngeal Training in Post-stroke Dysphagia During Early Rehabilitation

Conditions
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Stroke, Acute, Dysphagia, Pneumonia

Intervention / Treatment
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* Device: Repetitve transcranial magnetic stimulation
* Device: Sham transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients were diagnosed of stroke oropharyngeal dysphagia by a neurologist. Sever to moderate dysphagia (GUSS 0-14). Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16). Patients' age ranged from 49 to 65 years old. Patients had the ability to understand and follow instructions. Patients were able to sit in upright position. Exclusion Criteria: History of previous stroke. History of any swallowing problem. History of any head and neck surgery or tumor that causes swallowing dysfunction. Any lung disease or pneumonia on admission. Patients with cognitive deficits or disturbed conscious level. Patients on mechanical ventilator. Patients with sensory or global aphasia.

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 65 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
Interventional Model Description: Randomized Controlled Clinical trial, where the recruited patients will be randomly assigned into 2 equal groups ( GA & GB) using sealed envelopes, control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consists of: ice massage, oromotor exercises, Masako maneuver, resisted jaw opening exercise, modified chin tuck against resistance, Mandelson maneuver, effortful swallow and chin tuck in addition to sham repetitive transcranial magnetic stimulation. Patients in (GB) will be treated by low frequency (1 Hz) rTMS to the contralesional cerebral hemisphere in addition to the same Oropharyngeal physical therapy program for dysphagia as in group A.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group (GA)<br>Group (A) will receive conventional Oropharyngeal physical therapy program for dysphagia including; Exercise therapy for the oropharyngeal and tongue muscles , neuromuscular electrical stimulation in addition to sham transcranial magnetic stimulation on the contralesional cerebral hemisphere. | Device: Sham transcranial magnetic stimulation<br>* Repetitive TMS via a sham Magstim coil (identical appearance and noise, but no active stimulation). Identical stimulation schedules as patients in study group.<br>|
| Active Comparator: Study group (GB)<br>Group (B) will received low frequency (1 Hz) repetitive transcranial magnetic stimulation to the contralesional cerebral hemisphere in addition to the same Oropharyngeal physical therapy program for dysphagia as in group A. | Device: Repetitve transcranial magnetic stimulation<br>* The Magstim Rapid2 magnetic stimulator system (Model P/N 3576-23-09, Magstim Company, Whitland, UK) was used to deliver rTMS electrical currents via a figure of 8 coil applied to the scalp against the targeted contralesional motor  Hot spot , at a depth of approximately 1 cm . The inhibitory rTMS will be applied to the intact cerebral hemisphere at 1 Hz with a train of 1200 for 5 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mann Assessment of Swallowing Ability (MASA) | Screening tool for identifying eating and swallowing disorders in acute stroke , used to quantify aspiration risk via bedside test predicting dysphagia and aspiration in stroke 24 clinical items General patient examination (alertness, cooperation, auditory comprehension, aphasia, apraxia, and dysarthria) 5-point to 10-point rating scale Total score: 200 points cut off is 177 points Risk of Dysphagia: No abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), severe dysphagia (≤138) Risk of Aspiration: no abnormality (≥170), mild (149-169), moderate (141-148), severe (≤140). | Baseline and immediately after the intervention. | 
| The Gugging swallowing screen (GUSS) | It's a valid and a reliable bedside screening test to detect dysphagia and aspiration risk. The GUSS has 100% sensitivity. It begins with simple indirect swallow screen then if the total score is reached a direct swallowing test is done. It's composed of three parts: semisolid swallowing trial, liquid swallowing trial and solid swallowing trial. GUSS total score is 20. The score of the preliminary or the direct test is five. If the total score is reached the direct test can be done. Each subitem in the direct test has a score of five points. Each item of them requires the previous item to be completed. | Baseline and immediately after the intervention. | 
| (A2DS2) scale to detect risk of pneumonia | A2DS2 scale is used to detect stroke associated pneumonia (SAP). Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia. | Baseline and immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Temperature | According to the diagnostic criteria of stroke associated pneumonia (SAP): follow the modified Center for Disease Control and Prevention (CDC), All patients that were suspected to had pneumonia and their vitals followed the criteria of the CDC . Body temperature was one of the vitals that confirm pneumonia, Fever (>38°C) with no other recognized cause is one of the diagnostic criteria for pneumonia. | Baseline and immediately after the intervention. | 
| Total Leukocyte Count (TLC) | According to the diagnostic criteria of SAP follow the modified Center for Disease Control and Prevention (CDC), All patients that were suspected to had pneumonia and their vitals followed the criteria of the CDC. Leukopenia (<4000 WBC/mm3) or leukocytosis (>12 000 WBC/mm3). A blood sample is taken from the patient to assess the total leukocyte count. | Baseline and immediately after the intervention. | 
| Arterial Blood Gas (ABG) Test to assess Oxygen Saturation (OS) | According to the diagnostic criteria of SAP follow the modified Center for Disease Control and Prevention (CDC), All patients that were suspected to had pneumonia and their vitals followed the criteria of the CDC. TLC to assess worsening gas exchange (e.g., O2 desaturation [e.g., PaO2/FiO2≤240], increased oxygen requirements*) by taking a blood sample from the patient. | Baseline and immediately after the intervention. | 
| Respiratory Rate (RR) | Fast breathing was found to be the most useful sign predicting Stroke associated pneumonia (SAP) for both male and female patients . | Baseline and immediately after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Dysphagia, Stroke Associated Pneumonia (SAP), Repetitive Transcranial Magnetic Stimulation, Contralesional hemisphere