Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia

Launched by INSTITUTE OF PSYCHIATRY AND NEUROLOGY, WARSAW · Mar 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have difficulty speaking or understanding language after having a stroke, a condition known as aphasia. The researchers want to see if a non-invasive technique called Theta Burst Stimulation (TBS) can help improve language skills when combined with traditional speech and language therapy. In this trial, 45 right-handed Polish speakers aged 18 to 75 who have experienced their first stroke and have non-fluent aphasia will be recruited. Participants will be randomly assigned to one of three groups: one will receive stimulation aimed at enhancing the left side of the brain (which controls language), another will receive stimulation to inhibit the right side, and the third group will receive a placebo treatment for comparison.

If you or someone you know is eligible for this study, you can expect to participate in 15 sessions of this stimulation over three weeks, followed by individual speech therapy after each session. The researchers will assess language skills before and after the treatment, as well as three months later, to see how well the therapy works. This trial aims to improve understanding of how the brain recovers language function after a stroke and to explore new ways to support recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • First-ever left middle cerebral artery ischemic stroke (brain damage localization confirmed by magnetic resonance imaging, MRI)
• • 3 or more months from the onset of stroke
• • Non-fluent aphasia (confirmed in the BDAE test) with functional communication difficulties ranging from mild to significant (grades from 2 to 4 in ASRS), marked difficulties in naming, and relatively preserved everyday speech comprehension
• • Native Polish speaker
• • Right-handedness prior to stroke
• • Signing of the informed consent for the participation in the study.
• Exclusion Criteria:
• • Psychiatric and/or neurological comorbidity (e. g. dementia, depressive disorder, alcohol dependence)
• • Diagnose of epilepsy or epileptic changes in EEG, also frequent losses of consciousness of unclear etiology which might suggest epileptic seizures
• • History of any neurosurgical procedure around the head area
• • 1.5 T MRI examination contraindications (metal elements in the body, e. g. implantable cardioverter-defibrillator, deep brain stimulation devices; claustrophobia)
• • Regular intake of medication that could affect cortical excitability (e. g. antiepileptic or antipsychotic drugs, antidepressants, benzodiazepines) or medication influencing neuroplastic processes (e. g. dopamine)
• • Significant cognitive impairment limiting patient's cooperation during assessment and behavioral aphasia therapy
• • Visual deficits significantly hindering the perception of therapeutic tasks presented visually on a computer's screen
• • New neurological episode (e. g. another brain stroke) or somatic illness (e. g. COVID-19) during the cycle of the therapy, requiring its interruption.