An interventional study of Noninvasive transcranial brain stimulation: excitatory iTBS and Noninvasive transcranial brain stimulation: inhibitory cTBS in Stroke, Ischemic and Aphasia Non Fluent, sponsored by Institute of Psychiatry and Neurology, Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Institute of Psychiatry and Neurology, Warsaw · Not applicable, Interventional, and Treatment
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 functional recovery in the first months post stroke and language improvement due to application of behavioral speech and language therapy (SLT), many aphasic patients do not achieve satisfactory level of verbal communication. The aim of the planned study is to explore the potential of the noninvasive repetitive Transcranial Magnetic Stimulation (rTMS) as a therapeutic tool for aphasia in addition to traditional behavioral therapy. In case of aphasia, studies on therapeutic effectiveness of rTMS aim to increase the activity of the language-dominant left cerebral hemisphere, which may be achieved in an indirect manner by inhibiting the activity of the opposite (right) hemisphere or in a direct manner by increasing the excitability of preserved language areas in the left hemisphere. In our study, we plan to administer the newest form of rTMS called Theta Burst Stimulation (TBS), which is safer than the conventional rTMS, even when used in the perilesional area. Computer-based neuronavigation system will be implemented to precisely localize stimulation targets, control administration of stimuli during rTMS sessions, and evaluate differences between participants regarding deviations from established stimulation points. 45 patients (all right-handed, polish native speakers, aged 18-75 years, diagnosed with non-fluent aphasia) will be enrolled in a randomized, double-blind, sham-controlled trial. Subjects will be randomly assigned to one of the three groups: 1) a group with excitatory intermittent TBS of the left hemisphere (iTBS group), 2) a group with inhibitory continuous TBS of the right hemisphere (cTBS group), 3) a group with sham TBS (sTBS group as a control group). Specific forms of stimulation will be carried out for three consecutive weeks (Monday to Friday; a total of 15 stimulation sessions). Immediately after each session of the stimulation, patients will undergo individual SLT. Assessment of language functioning will be carried out three times: before and after the therapy period, and 3 months after its completion. Results of the study will broaden knowledge about hemispherical mechanisms of language and speech recovery after stroke and provide insight into possibilities of their modulation for the purpose of post-stroke rehabilitation.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 45 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Institute of Psychiatry and Neurology, Warsaw is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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15 sessions of 200-second of iTBS over the pars triangularis of Broca's area in the left hemisphere (BA 45), preceding 45-minutes of behavioral aphasia therapy.
Device: Noninvasive transcranial brain stimulation: excitatory iTBS · Behavioral: Individual speech-language therapy (SLT)
15 sessions of 40 seconds of cTBS over the pars triangularis of the right inferior frontal gyrus (BA 45 homologue), preceding 45-minutes of behavioral aphasia therapy.
Device: Noninvasive transcranial brain stimulation: inhibitory cTBS · Behavioral: Individual speech-language therapy (SLT)
15 sessions of sham TBS over the pars triangularis of Broca's area in the left hemisphere (BA 45), preceding 45-minutes of behavioral aphasia therapy.
Behavioral: Individual speech-language therapy (SLT) · Device: Sham TBS simulating left hemispheric iTBS
600 pulses (3 pulses at 50 Hz given every 200 milliseconds in 2-second trains at 10-second intervals, delivered at 80% of active motor threshold) generated by Magstim Super Rapid2 stimulator equipped with a figure-of-eight coil applied over BA 45 Device: Magstim Co., Wales, UK.
Also known as: Magstim Super Rapid2
600 pulses (3 pulses at 50 Hz, repeated at 5 Hz, delivered at 80% of active motor threshold) generated by Magstim Super Rapid2 stimulator equipped with a figure-of-eight coil applied over BA 45 homologue Device: Magstim Co., Wales, UK.
Also known as: Magstim Super Rapid2
45 minutes training tailored to every patient's deficits, abilities and needs. Exercises used during each therapeutic session include: expressions tasks (naming and sentence building), complex utterances comprehension tasks, reading and writing exercises. Training is administered using paper-and-pencil tasks and computerized aphasia therapy program AfaSystem (Harpo sp.zoo, Poznań, Poland).
Sham TMS coil positioned exactly like an active TMS coil resulting in a very good approximation of the auditory effects Device: Magstim Co., Wales, UK.
Also known as: Magstim Super Rapid2
Change from pre-treatment assessment in the performance on a picture naming task
Total number of correctly named items (assessed: accuracy and speed of naming) from a set of 250 visually presented objects (200 noun names and 50 verb names; stimuli included in the set are diversified with regard to the articulation difficulty of corresponding words and their usage frequency in everyday speech).
Time frame: Pre-treatment assessment (within 2 days before starting the intervention), post-treatment assessment (within 2 days of completing the 15 days intervention)
Change from pre-treatment in the performance on the picture naming task at 3 months post-therapy (follow up assessment)
Total number of correctly named items from a set of 250 visually presented objects.
Time frame: Pre-treatment and 3 months follow-up (post-treatment) assessment
Change from post-treatment in the performance on the picture naming task at 3 months post-therapy
Total number of correctly named items from a set of 250 visually presented objects.
Time frame: Post-treatment and 3 months follow-up assessment
Change from pre-treatment assessment in the performance on a scene description task of three visually presented scenes
(assessed: length and correctness of utterances).
Time frame: Pre-treatment assessment, post-treatment assessment (within 2 days of completing the 15 days intervention)
Change from pre-treatment in the scene description task at 3 months post-therapy
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Time frame: Pre-treatment and 3 months follow-up
Change from post-treatment in the scene description task at 3 months post-therapy
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Time frame: Post-treatment and 3 months follow-up
Change from pre-treatment on the semantic fluency task
Producing within a minute as many words as possible from 3 semantic categories: animals, fruit, clothes; assessed: total number of correctly generated items.
Time frame: Pre-treatment and post-treatment (within 2 days of completing the 15 days intervention)
Change from pre-treatment on the semantic fluency task at 3 months post-therapy
Total number of correctly generated items such as animals, fruits, clothes.
Time frame: Pre-treatment and 3 months follow-up
Change from post-treatment on the semantic fluency task at 3 months post-therapy
Total number of correctly generated items such as animals, fruits, clothes.
Time frame: Post-treatment and 3 months follow-up
Modified Communication Effectiveness Index (CETI)
A questionnaire to complete by researcher and family member/caregiver. Contains descriptions of ten communication situations, patients' performance in each of them is assessed on a Likert-type scale (from 0 to 7). Higher score means better functional communication.
Time frame: Pre-treatment, post-treatment (within 2 days of completing the 15 day intervention) and on 3-month follow-up
The Polish version of short form of the Boston Diagnostic Aphasia Examination (BDAE)
Assesses the linguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia. Includes the six-point Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS; 0-5 points - lower score means more severe language impairment).
Time frame: Screening appointment (pre-enrollment assessment)
Plan to share: Undecided
Started Sep 2022 (actual). Primary completion is estimated for Dec 2027, 63 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 63 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Institute of Psychiatry and Neurology, Warsaw