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NCT Number: NCT06123650

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

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Infections Lung Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases

Age range

49 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repetitve transcranial magnetic stimulation

Device

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

Device

Repetitive TMS via a sham Magstim coil (identical appearance and noise, but no active stimulation). Identical stimulation schedules as patients in study group.

Primary outcomes

  1. The Gugging swallowing screen (GUSS)

    Time frame: 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.

  2. (A2DS2) scale to detect risk of pneumonia

    Time frame: 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.

  3. Microbiological Examination of the sputum

    Time frame: 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 outcomes

  1. Body Temperature

    Time frame: 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.

  2. Total Leukocyte Count (TLC)

    Time frame: 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.

  3. Arterial Blood Gas (ABG) Test to assess Oxygen Saturation (OS)

    Time frame: 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.

  4. Respiratory Rate (RR)

    Time frame: 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 .

Other outcomes

  1. Mann Assessment of Swallowing Ability (MASA)

    Time frame: Baseline

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Engy B. Moustafa, PhD

CONTACT

[email protected]

00201099445112

Moshera H. Darwish, PhD

CONTACT

[email protected]

00201015163617

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated Pneumonia.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 9, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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