Stroke, AcuteNCT06123650
Post Stroke Dysphagia: Effect of Adding rTMS to Conventional Therapy on the Prevalence of Pneumonia.
A study testing Repetitve transcranial magnetic stimulation in people with Stroke, Acute and Dysphagia, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 49 to 65 years
- Conditions the study is for
- Stroke, Acute, Dysphagia, Pneumonia
- What is being tested?
- Repetitve transcranial magnetic stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2025to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 11432
Engy B. Moustafa, PhD, 00201099445112, engybm.saleh@cu.edu.eg
Moshera H. Darwish, PhD, 00201015163617, dr.moshera11@yahoo.com
About this study
Official title: Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated 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.
Read the 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.
- Conditions
- Stroke, Acute, Dysphagia, Pneumonia
- Being tested
- Repetitve transcranial magnetic stimulation, Sham transcranial magnetic stimulation
- Keywords
- Stroke, Dysphagia, Stroke Associated Pneumonia (SAP), Repetitive Transcranial Magnetic Stimulation, Contralesional hemisphere
- Medical subject headings
- Stroke, Deglutition Disorders, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitve transcranial magnetic stimulationDevice
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 stimulationDevice
Repetitive TMS via a sham Magstim coil (identical appearance and noise, but no active stimulation). Identical stimulation schedules as patients in study group.
| Study group | Role | What they receive |
|---|---|---|
| Control group (GA) | Placebo comparator | Group (A) will receive conventional oral care and oropharyngeal physical therapy program for dysphagia including; Exercise therapy for the oropharyngeal and tongue muscles , in addition to sham transcranial magnetic stimulation on the contralesional cerebral hemisphere. Receives: Device: Sham transcranial magnetic stimulation |
| Study group (GB) | Active comparator | 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. Receives: Device: Repetitve transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after the intervention.
Microbiological Examination of the sputum
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 .
Measured: Baseline and immediately after the intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: Baseline and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start22 Mar 2025
- Primary completion28 Dec 2025 (estimated)
- Study completion27 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Badreldin Saleh Moustafa, PhD, Cairo University
- Investigators
- Engy B. Moustafa, PhD, Principal investigator, Faculty of Physical Therapy, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123650
- Sponsor's protocol ID
- P.T.REC/012/004748
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated Pneumonia.
- ClinicalTrials.gov ID
- NCT06123650
- Acronym / sponsor ID
- P.T.REC/012/004748
- Conditions
- Stroke, Acute, Dysphagia, Pneumonia
- Keywords
- Stroke, Dysphagia, Stroke Associated Pneumonia (SAP), Repetitive Transcranial Magnetic Stimulation, Contralesional hemisphere
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 27 Jan 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group (GA) | Placebo comparator | Device: Sham transcranial magnetic stimulationGroup (A) will receive conventional oral care and oropharyngeal physical therapy program for dysphagia including; Exercise therapy for the oropharyngeal and tongue muscles , in addition to sham transcranial magnetic stimulation on the contralesional cerebral hemisphere. |
| Study group (GB) | Active comparator | Device: Repetitve transcranial magnetic stimulationGroup (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. |
Who may qualify
- Ages
- 49 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitve transcranial magnetic stimulationThe 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. | Device | Study group (GB) |
| Sham transcranial magnetic stimulationRepetitive TMS via a sham Magstim coil (identical appearance and noise, but no active stimulation). Identical stimulation schedules as patients in study group. | Device | Control group (GA) |
Primary outcome
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.
(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.
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 .
4 secondary outcomes
Body Temperature
Time frame: Baseline and immediately after the intervention.
Total Leukocyte Count (TLC)
Time frame: Baseline and immediately after the intervention.
Arterial Blood Gas (ABG) Test to assess Oxygen Saturation (OS)
Time frame: Baseline and immediately after the intervention.
Respiratory Rate (RR)
Time frame: Baseline and immediately after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Engy B. Moustafa, PhD principal investigator
Faculty of Physical Therapy, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitve transcranial magnetic stimulation in people with Stroke, Acute and Dysphagia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Engy B. Moustafa, PhD (00201099445112, engybm.saleh@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gugging swallowing screen (GUSS) (time frame: Baseline and immediately after the intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.