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

NCT06123650 | Recruiting

• 1 other identifier: P.T.REC/012/004748
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Dysphagia; Pneumonia

Keywords

Stroke; Dysphagia; Stroke Associated Pneumonia (SAP); Repetitive Transcranial Magnetic Stimulation; Contralesional hemisphere

Outcome Measures

Primary Outcomes (3)

• 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.

• (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.

• 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 .

  Baseline and immediately after the intervention

Secondary Outcomes (4)

• Body Temperature

  Baseline and immediately after the intervention.

• Total Leukocyte Count (TLC)

  Baseline and immediately after the intervention.

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

  Baseline and immediately after the intervention.

• Respiratory Rate (RR)

  Baseline and immediately after the intervention.

Other Outcomes (1)

• Mann Assessment of Swallowing Ability (MASA)

  Baseline

Study Arms (2)

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.

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.

Device: Repetitve transcranial magnetic stimulation

Interventions

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.

Study group (GB)

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.

Control group (GA)

Eligibility Criteria

• Age: 49 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders; Pneumonia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Engy B. Moustafa, PhD

  Faculty of Physical Therapy, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engy B. Moustafa, PhD

CONTACT

00201099445112; engybm.saleh@cu.edu.eg

Moshera H. Darwish, PhD

CONTACT

00201015163617; dr.moshera11@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients participated will be masked about the type of intervention, where (GA) patients will receive PT program + sham repetitive transcranial magnetic stimulation, while patients in (GB) will receive 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for Neurology and Neurosurgery

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: March 22, 2025
• Primary Completion: December 28, 2025
• Study Completion: January 27, 2026
• Last Updated: October 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)