Post Stroke Dysphagia: Effect of Adding rTMS to Conventional Therapy on the Prevalence of Pneumonia.
NCT ID: NCT06123650
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-03-22
2026-01-27
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group (GA)
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.
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.
Study group (GB)
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
49 Years
65 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Engy Badreldin Saleh Moustafa, PhD
Lecturer of Physical Therapy for Neurology and Neurosurgery
Principal Investigators
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Engy B. Moustafa, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Physical Therapy, Cairo University, Egypt
Locations
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Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P.T.REC/012/004748
Identifier Type: -
Identifier Source: org_study_id
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