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NCT Number: NCT05303649

Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia

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.

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Key information

Conditions

Stroke, Ischemic Aphasia Aphasia Non Fluent Aphasia, Broca Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Ischemic Stroke Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychiatry and Neurology

Warsaw, Masovian Voivodeship, Poland

Location status: Recruiting

Location contact

Katarzyna E Polanowska, PhD

CONTACT

[email protected]

+48224582870

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noninvasive transcranial brain stimulation: excitatory iTBS

Device

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.

Other names: Magstim Super Rapid2

Noninvasive transcranial brain stimulation: inhibitory cTBS

Device

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.

Other names: Magstim Super Rapid2

Individual speech-language therapy (SLT)

Behavioral

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 iTBS

Device

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.

Other names: Magstim Super Rapid2

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. The Polish version of short form of the Boston Diagnostic Aphasia Examination (BDAE)

    Time frame: Screening appointment (pre-enrollment assessment)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Katarzyna E Polanowska, PhD

CONTACT

[email protected]

+48224582870

Szczepan Iwański, PhD

CONTACT

[email protected]

+48224582870

Sponsors and collaborators

Lead sponsor

Institute of Psychiatry and Neurology, Warsaw

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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