Using brain stimulation to improve language skills after a stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of noninvasive repetitive Transcranial Magnetic Stimulation (rTMS) combined with traditional speech-language therapy for patients suffering from non-fluent aphasia following a left middle cerebral artery ischemic stroke. The approach aims to enhance the activity of the language-dominant left hemisphere by either inhibiting the right hemisphere or directly stimulating preserved language areas. Participants will receive either excitatory or inhibitory brain stimulation alongside individual speech-language therapy, with a focus on improving communication abilities. The study targets patients who have experienced their first stroke at least three months prior and are native Polish speakers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Psychiatry and Neurology
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Katarzyna E Polanowska, PhD — Institute of Psychiatry and Neurology, Warsaw, Poland
• Study coordinator: Katarzyna E Polanowska, PhD
• Email: kpolanowska@ipin.edu.pl
• Phone: +48224582870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.