Using brain stimulation to improve language skills after a stroke
Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
This study is testing if combining brain stimulation with speech therapy can help Polish-speaking patients improve their language skills after having a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Psychiatry and Neurology, Warsaw Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT05303649 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are right-handed native Polish speakers who have experienced their first left middle cerebral artery ischemic stroke and have non-fluent aphasia.
Not a fit: Patients with psychiatric or neurological comorbidities, epilepsy, or contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve verbal communication abilities in patients with post-stroke aphasia.
How similar studies have performed: Previous studies have shown promising results using rTMS for aphasia treatment, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Warsaw, Masovian Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.