Repetitive transcranial magnetic stimulation for language recovery in post-stroke non-fluent aphasic patients: a randomized sham-controlled clinical trial

Abstract

Background: Stroke is the second cause of death and a major cause of morbidity worldwide and approximately 1/3 of the patients who suffer a stroke, remain with aphasia. Aphasia is one of the most disabling sequelae of stroke, it affects the quality of life of the patients and has a huge impact on personal, social, familiar, and work-life. Nowadays, aphasia has no specific treatment, and its management is based on speech therapy which obtains limited results. Repetitive transcranial magnetic stimulation is a non-invasive, low-cost, and available technique that has shown a potential therapeutic effect on recent literature. However, the evidence is still week due to the lack of standardized stimulation protocols, the variability of the study population, and the number of resources needed to perform these studies. Objectives: To assess the clinical efficacy of repetitive transcranial magnetic stimulation combined with intensive speech therapy in subacute post-stroke patients with aphasia in language rehabilitation assessed using the Boston Diagnostic Aphasia Examination. Secondary objectives include evaluating its effect on the quality of life and mood of these patients.

Design and methods: A randomized, double-blind (single-blinded in the stimulation session), sham- controlled clinal trial performed in Hospital Josep Trueta of Girona. It will recruit 64 patients using a

consecutive non-probabilistic method. Patients recruitment will last for 1 year. Patients will be randomized in the experimental group that will receive real-rTMS or in the control group that will receive sham-rTMS following a 1:1 ratio. The randomization will be stratified by stroke type (ischemic or hemorrhagic). Patients will be administered the assigned stimulation 5 days/week for 2 weeks. The stimulation session will take 20 min and immediately after it, patients will receive a 45-minute speech and language therapy. Patients will be assessed for the measure endpoints of the study (subtests of BDAE which are BNT, fluency, repetition, and comprehension tests) before the stimulation, after the stimulation period and they will be followed-up after 6 months and 12 months. A general linear model will be performed to study the effect of the intervention on the endpoint of the study adjusting for potential confounding variables