Effect of rTMS on pneumonia in stroke patients with swallowing difficulties
Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated Pneumonia.
This study tests if adding a special brain treatment to regular therapy can help stroke patients with swallowing problems avoid pneumonia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 49 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza, Giza Governorate) |
| Trial ID | NCT06123650 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of adding low-frequency repetitive transcranial magnetic stimulation (rTMS) to conventional physical therapy for patients suffering from dysphagia after an acute ischemic stroke. Seventy patients will be randomly assigned to either a control group receiving sham rTMS or a study group receiving actual rTMS alongside a designed rehabilitation program. The study aims to assess the prevalence of aspiration pneumonia in these patients, utilizing various assessments to confirm dysphagia and pneumonia risk. The intervention consists of 12 sessions over four weeks, focusing on improving swallowing coordination and reducing pneumonia risk.
Who should consider this trial
Good fit: Ideal candidates are acute ischemic stroke patients aged 49 to 65 with moderate to severe dysphagia.
Not a fit: Patients with a history of previous strokes, cognitive deficits, or existing lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of aspiration pneumonia in stroke patients with dysphagia.
How similar studies have performed: While rTMS has shown promise in improving dysphagia, its specific effect on pneumonia prevalence in stroke patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Giza, Giza Governorate
- Faculty of Physical Therapy, Cairo University — Giza, Giza Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Engy B. Moustafa, PhD — Faculty of Physical Therapy, Cairo University, Egypt
- Study coordinator: Engy B. Moustafa, PhD
- Email: engybm.saleh@cu.edu.eg
- Phone: 00201099445112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.