Stroke, IschemicNCT05303649
Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
A study testing Noninvasive transcranial brain stimulation: excitatory iTBS, Noninvasive transcranial brain stimulation: inhibitory cTBS and Individual speech-language therapy (SLT) in people with Stroke, Ischemic and Aphasia Non Fluent, run by Institute of Psychiatry and Neurology, Warsaw at 1 site in Poland.
Trial 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 functional recovery in the first months post stroke and language improvement due to application of behavioral speech and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Aphasia Non Fluent
- What is being tested?
- Noninvasive transcranial brain stimulation: excitatory iTBS, Noninvasive transcranial brain stimulation: inhibitory cTBS and Individual speech-language therapy (SLT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- 2 Sep 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Institute of Psychiatry and Neurology
Warsaw, Masovian Voivodeship
Katarzyna E Polanowska, PhD, +48224582870, kpolanowska@ipin.edu.pl
About this study
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.
- Conditions
- Stroke, Ischemic, Aphasia Non Fluent
- Being tested
- Noninvasive transcranial brain stimulation: excitatory iTBS, Noninvasive transcranial brain stimulation: inhibitory cTBS, Individual speech-language therapy (SLT), Sham TBS simulating left hemispheric iTBS
- Keywords
- Aphasia, Stroke, Theta Burst Stimulation, Therapy, Rehabilitation, Noninvasive Transcranial Brain Stimulation
- Medical subject headings
- Ischemic Stroke, Aphasia, Broca, Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive transcranial brain stimulation: excitatory iTBSDevice
Also called Magstim Super Rapid2
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.
Noninvasive transcranial brain stimulation: inhibitory cTBSDevice
Also called 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.
Individual speech-language therapy (SLT)Behavioural
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 TBS simulating left hemispheric iTBSDevice
Also called Magstim Super Rapid2
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy | Experimental | 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. Receives: Device: Noninvasive transcranial brain stimulation: excitatory iTBS; Behavioral: Individual speech-language therapy (SLT) |
| Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy | Experimental | 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. Receives: Device: Noninvasive transcranial brain stimulation: inhibitory cTBS; Behavioral: Individual speech-language therapy (SLT) |
| Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy | Sham comparator | 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. Receives: Behavioral: Individual speech-language therapy (SLT); Device: Sham TBS simulating left hemispheric iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-treatment and 3 months follow-up
Secondary outcomes (1)
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.
Measured: Pre-treatment, post-treatment (within 2 days of completing the 15 day intervention) and on 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry and Neurology, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Polanowska, Institute of Psychiatry and Neurology, Warsaw
- Investigators
- Katarzyna E Polanowska, PhD, Principal investigator, Institute of Psychiatry and Neurology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303649
- Sponsor's protocol ID
- IPiN_KP01
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harvey DY, Mass JA, Shah-Basak PP, Wurzman R, Faseyitan O, Sacchetti DL, DeLoretta L, Hamilton RH. Continuous theta burst stimulation over right pars triangularis facilitates naming abilities in chronic post-stroke aphasia by enhancing phonological access. Brain Lang. 2019 May;192:25-34. doi: 10.1016/j.bandl.2019.02.005. Epub 2019 Mar 11.
PubMed 30870740Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
PubMed 15664172Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.
PubMed 21221011Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Screening questionnaire before TMS: an update. Clin Neurophysiol. 2011 Aug;122(8):1686. doi: 10.1016/j.clinph.2010.12.037. Epub 2011 Jan 11. No abstract available.
PubMed 21227747Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PubMed 19833552Shah PP, Szaflarski JP, Allendorfer J, Hamilton RH. Induction of neuroplasticity and recovery in post-stroke aphasia by non-invasive brain stimulation. Front Hum Neurosci. 2013 Dec 24;7:888. doi: 10.3389/fnhum.2013.00888.
PubMed 24399952Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
PubMed 21842404Szaflarski JP, Griffis J, Vannest J, Allendorfer JB, Nenert R, Amara AW, Sung V, Walker HC, Martin AN, Mark VW, Zhou X. A feasibility study of combined intermittent theta burst stimulation and modified constraint-induced aphasia therapy in chronic post-stroke aphasia. Restor Neurol Neurosci. 2018;36(4):503-518. doi: 10.3233/RNN-180812.
PubMed 29889086Szaflarski JP, Vannest J, Wu SW, DiFrancesco MW, Banks C, Gilbert DL. Excitatory repetitive transcranial magnetic stimulation induces improvements in chronic post-stroke aphasia. Med Sci Monit. 2011 Feb 25;17(3):CR132-9. doi: 10.12659/msm.881446.
PubMed 21358599Ball LJ, Beukelman DR, Pattee GL. Communication effectiveness of individuals with amyotrophic lateral sclerosis. J Commun Disord. 2004 May-Jun;37(3):197-215. doi: 10.1016/j.jcomdis.2003.09.002.
PubMed 15063143
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT05303649
- Acronym / sponsor ID
- IPiN_KP01
- Conditions
- Stroke, Ischemic, Aphasia Non Fluent
- Keywords
- Aphasia, Stroke, Theta Burst Stimulation, Therapy, Rehabilitation, Noninvasive Transcranial Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Institute of Psychiatry and Neurology, WarsawUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy | Experimental | Device: Noninvasive transcranial brain stimulation: excitatory iTBS, Behavioral: Individual speech-language therapy (SLT)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. |
| Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy | Experimental | Device: Noninvasive transcranial brain stimulation: inhibitory cTBS, 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. |
| Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy | Sham comparator | Behavioral: Individual speech-language therapy (SLT), Device: Sham TBS simulating left hemispheric iTBS15 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive transcranial brain stimulation: excitatory iTBSAlso: Magstim Super Rapid2600 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. | Device | Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy |
| Noninvasive transcranial brain stimulation: inhibitory cTBSAlso: Magstim Super Rapid2600 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. | Device | Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy |
| Individual speech-language therapy (SLT)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). | Behavioural | Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy, Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy, Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy |
| Sham TBS simulating left hemispheric iTBSAlso: Magstim Super Rapid2Sham TMS coil positioned exactly like an active TMS coil resulting in a very good approximation of the auditory effects Device: Magstim Co., Wales, UK. | Device | Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy |
Primary outcome
Change from pre-treatment assessment in the performance on a picture naming task
Time frame: Pre-treatment assessment (within 2 days before starting the intervention), post-treatment assessment (within 2 days of completing the 15 days intervention)
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).
Change from pre-treatment in the performance on the picture naming task at 3 months post-therapy (follow up assessment)
Time frame: Pre-treatment and 3 months follow-up (post-treatment) assessment
Total number of correctly named items from a set of 250 visually presented objects.
Change from post-treatment in the performance on the picture naming task at 3 months post-therapy
Time frame: Post-treatment and 3 months follow-up assessment
Total number of correctly named items from a set of 250 visually presented objects.
Change from pre-treatment assessment in the performance on a scene description task of three visually presented scenes
Time frame: Pre-treatment assessment, post-treatment assessment (within 2 days of completing the 15 days intervention)
(assessed: length and correctness of utterances).
Change from pre-treatment in the scene description task at 3 months post-therapy
Time frame: Pre-treatment and 3 months follow-up
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Change from post-treatment in the scene description task at 3 months post-therapy
Time frame: Post-treatment and 3 months follow-up
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Change from pre-treatment on the semantic fluency task
Time frame: Pre-treatment and post-treatment (within 2 days of completing the 15 days intervention)
Producing within a minute as many words as possible from 3 semantic categories: animals, fruit, clothes; assessed: total number of correctly generated items.
Change from pre-treatment on the semantic fluency task at 3 months post-therapy
Time frame: Pre-treatment and 3 months follow-up
Total number of correctly generated items such as animals, fruits, clothes.
Change from post-treatment on the semantic fluency task at 3 months post-therapy
Time frame: Post-treatment and 3 months follow-up
Total number of correctly generated items such as animals, fruits, clothes.
1 secondary outcome
Modified Communication Effectiveness Index (CETI)
Time frame: Pre-treatment, post-treatment (within 2 days of completing the 15 day intervention) and on 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 30870740Harvey DY, Mass JA, Shah-Basak PP, Wurzman R, Faseyitan O, Sacchetti DL, DeLoretta L, Hamilton RH. Continuous theta burst stimulation over right pars triangularis facilitates naming abilities in chronic post-stroke aphasia by enhancing phonological access. Brain Lang. 2019 May;192:25-34. doi: 10.1016/j.bandl.2019.02.005. Epub 2019 Mar 11.
- Background: PubMed 15664172Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Background: PubMed 21221011Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.
- Background: PubMed 21227747Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Screening questionnaire before TMS: an update. Clin Neurophysiol. 2011 Aug;122(8):1686. doi: 10.1016/j.clinph.2010.12.037. Epub 2011 Jan 11. No abstract available.
- Background: PubMed 19833552Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Background: PubMed 24399952Shah PP, Szaflarski JP, Allendorfer J, Hamilton RH. Induction of neuroplasticity and recovery in post-stroke aphasia by non-invasive brain stimulation. Front Hum Neurosci. 2013 Dec 24;7:888. doi: 10.3389/fnhum.2013.00888.
- Background: PubMed 21842404Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
- Background: PubMed 29889086Szaflarski JP, Griffis J, Vannest J, Allendorfer JB, Nenert R, Amara AW, Sung V, Walker HC, Martin AN, Mark VW, Zhou X. A feasibility study of combined intermittent theta burst stimulation and modified constraint-induced aphasia therapy in chronic post-stroke aphasia. Restor Neurol Neurosci. 2018;36(4):503-518. doi: 10.3233/RNN-180812.
- Background: PubMed 21358599Szaflarski JP, Vannest J, Wu SW, DiFrancesco MW, Banks C, Gilbert DL. Excitatory repetitive transcranial magnetic stimulation induces improvements in chronic post-stroke aphasia. Med Sci Monit. 2011 Feb 25;17(3):CR132-9. doi: 10.12659/msm.881446.
- Background: PubMed 15063143Ball LJ, Beukelman DR, Pattee GL. Communication effectiveness of individuals with amyotrophic lateral sclerosis. J Commun Disord. 2004 May-Jun;37(3):197-215. doi: 10.1016/j.jcomdis.2003.09.002.
- Individual participant dataSharing planned: Undecided
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Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarzyna E Polanowska, PhD principal investigator
Institute of Psychiatry and Neurology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive transcranial brain stimulation: excitatory iTBS, Noninvasive transcranial brain stimulation: inhibitory cTBS and Individual speech-language therapy (SLT) in people with Stroke, Ischemic and Aphasia Non Fluent, run by Institute of Psychiatry and Neurology, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna E Polanowska, PhD (+48224582870, kpolanowska@ipin.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pre-treatment assessment in the performance on a picture naming task (time frame: Pre-treatment assessment (within 2 days before starting the intervention), post-treatment assessment (within 2 days of completing the 15 days intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303649, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.