Clinical trial NCT06123650: Post Stroke Dysphagia: Effect of Adding rTMS to Conventional Therapy on the Prevalence of Pneumonia.
Official title: Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated Pneumonia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Dysphagia
Pneumonia
Keywords: Stroke
Dysphagia
Stroke Associated Pneumonia (SAP)
Repetitive Transcranial Magnetic Stimulation
Contralesional hemisphere
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 70
Sex: ALL
Minimum age (years): 49
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The Gugging swallowing screen (GUSS)
timeFrame: Baseline and immediately after the intervention.
measure: (A2DS2) scale to detect risk of pneumonia
timeFrame: Baseline and immediately after the intervention.
measure: Microbiological Examination of the sputum
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Body Temperature
timeFrame: Baseline and immediately after the intervention.
measure: Total Leukocyte Count (TLC)
timeFrame: Baseline and immediately after the intervention.
measure: Arterial Blood Gas (ABG) Test to assess Oxygen Saturation (OS)
timeFrame: Baseline and immediately after the intervention.
measure: Respiratory Rate (RR)
timeFrame: Baseline and immediately after the intervention.
Other outcomes:
measure: Mann Assessment of Swallowing Ability (MASA)
timeFrame: Baseline
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
affiliation: Faculty of Physical Therapy, Cairo University, Egypt
name: Engy B. Moustafa, PhD
role: PRINCIPAL_INVESTIGATOR
References: