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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123650
• Other study ID #: P.T.REC/012/004748
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2023
• Est. completion date: July 28, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Engy BadrEldin S Moustafa, PhD
• Phone: 00201099445112
• Email: engybm.saleh[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 49 Years to 65 Years

Eligibility

Inclusion Criteria:

1. All the patients were diagnosed of stroke oropharyngeal dysphagia by a neurologist. Sever to moderate dysphagia (GUSS 0-14).

2. Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16).

3. Patients' age ranged from 49 to 65 years old.

4. Patients had the ability to understand and follow instructions.

5. Patients were able to sit in upright position.

Exclusion Criteria:

1. History of previous stroke.

2. History of any swallowing problem.

3. History of any head and neck surgery or tumor that causes swallowing dysfunction.

4. Any lung disease or pneumonia on admission.

5. Patients with cognitive deficits or disturbed conscious level.

6. Patients on mechanical ventilator.

7. Patients with sensory or global aphasia.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Pneumonia
• Stroke
• Stroke, Acute

Intervention

Device:
• Repetitve transcranial magnetic stimulation
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.
• Sham transcranial magnetic stimulation
Repetitive TMS via a sham Magstim coil (identical appearance and noise, but no active stimulation). Identical stimulation schedules as patients in study group.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza	Ad Doqi, Giza District, Giza Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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