Post Stroke Dysphagia: Effect of Adding rTMS to Conventional Therapy on the Prevalence of Pneumonia.

Not Applicable

Recruiting

• Conditions: Dysphagia; Pneumonia; Stroke, Acute
• Interventions: Device: Sham transcranial magnetic stimulation; Device: Repetitve transcranial magnetic stimulation

• Registration Number: NCT06123650
• Lead Sponsor: Cairo University

Brief 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 low frequency 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

Seventy acute ischemic stroke patients with oropharyngeal dysphagia from both sexes will represent the sample of this study. They will be diagnosed by a neurologist and stroke diagnosis was confirmed by brain MRI and/or CT. They will be selected from the stroke unit El Kasr El Ainy hospital, Cairo university.

Patients will be 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 a selected physical therapy rehabilitation program for oropharyngeal muscles in addition to sham repetitive transcranial magnetic stimulation. Study group (GB) will receive low frequency (1 Hz) rTMS to the contra-lesional cerebral hemisphere in addition to the same Oropharyngeal physical therapy program for dysphagia as in group A.

Modified Mann Assessment of Swallowing Ability (MASA) will initially used to confirm dysphagia in acute stroke. The Gugging swallowing screening (GUSS) test will be used to detect aspiration risk. A2DS2 scale will be used to detect stroke associated pneumonia (SAP). Criteria of modified Center for Disease Control and Prevention (CDC) will be used to assess SAP via assessing 4 main measures (body temperature (BT), Total Leukocyte count (TLC), Arterial blood gases (ABG), and Respiratory Rate (RR) .

The whole Intervention will consist of 12 sessions, 3 days /week for 4 consecutive weeks , Total duration of the session (TMS + PT session) will be from 40min to 60 min.

Primary \& secondary outcomes will be assessed at the baseline and immediately after the completion of the whole treatment program.

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-09
• Status Verified: 2024-06
• Study Start: 2024-07-22
• Primary Completion: 2025-04-28
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-07
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (GA)	Sham transcranial magnetic stimulation	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.
Study group (GB)	Repetitve transcranial magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
The Gugging swallowing screen (GUSS)	Baseline and immediately after the intervention.	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.
(A2DS2) scale to detect risk of pneumonia	Baseline and immediately after the intervention.	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.
Microbiological Examination of the sputum	Baseline and immediately after the intervention	Sputum specimens collected on sterile sputum containers by patient self-expectoration or aspiration should be checked for quality in a bacteriology laboratory. Quality check typically includes calculating the number of leukocytes (WBC) and buccal squamous epithelial (BSE) cells in the 100× view field .

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate (RR)	Baseline and immediately after the intervention.	Fast breathing was found to be the most useful sign predicting Stroke associated pneumonia (SAP) for both male and female patients .
Arterial Blood Gas (ABG) Test to assess Oxygen Saturation (OS)	Baseline and immediately after the intervention.	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.
Total Leukocyte Count (TLC)	Baseline and immediately after the intervention.	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.
Body Temperature	Baseline and immediately after the intervention.	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.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo University; 🇪🇬 Giza, Egypt