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

Sponsor
Cairo University
Study ID
NCT06123650
Status
Recruiting
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Conditions

  • Dysphagia
  • Pneumonia
  • Stroke, Acute

Eligibility Criteria

Sex
ALL
Age
49 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 9, 2023
Start date
Mar 22, 2025
Status verified
Dec 2024
Primary completion
Dec 28, 2025
Completion
Jan 27, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

The Gugging swallowing screen (GUSS) [ Time Frame: Baseline and immediately after the intervention. ]

Central Contacts

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