Post Stroke Dysphagia: Effect of Adding rTMS to Conventional Therapy on the Prevalence of Pneumonia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitve transcranial magnetic stimulation, Sham transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Stroke, Acute, Dysphagia, Pneumonia. Basic parameters: 49 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated Pneumonia.
Overview
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- The Gugging swallowing screen (GUSS) [Time frame: Baseline and immediately after the intervention.]
- (A2DS2) scale to detect risk of pneumonia [Time frame: Baseline and immediately after the intervention.]
- Microbiological Examination of the sputum [Time frame: Baseline and immediately after the intervention]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Physical Therapy, Cairo University — Giza
Identifiers
NCT: NCT06123650 · P.T.REC/012/004748