Status:
RECRUITING
Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
Lead Sponsor:
Institute of Psychiatry and Neurology, Warsaw
Conditions:
Stroke, Ischemic
Aphasia Non Fluent
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Aphasia is an impairment in the ability to express and/or understand language, commonly observed after stroke to the language dominant (left) hemisphere. Despite natural tendency to spontaneous functi...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05303649
Start Date
September 2 2022
End Date
December 1 2027
Last Update
October 4 2024
Active Locations (1)
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1
Institute of Psychiatry and Neurology
Warsaw, Masovian Voivodeship, Poland