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

Not Applicable

Recruiting

• Conditions: Stroke, Ischemic; Aphasia Non Fluent
• Interventions: Behavioral: Individual speech-language therapy (SLT); Device: Sham TBS simulating left hemispheric iTBS

• Registration Number: NCT05303649
• Lead Sponsor: Institute of Psychiatry and Neurology, Warsaw

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-09-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy	Sham TBS simulating left hemispheric iTBS	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.
Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy	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.
Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy	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.
Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from post-treatment on the semantic fluency task at 3 months post-therapy	Post-treatment and 3 months follow-up	Total number of correctly generated items such as animals, fruits, clothes.
Change from pre-treatment in the performance on the picture naming task at 3 months post-therapy (follow up assessment)	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 pre-treatment on the semantic fluency task	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 assessment in the performance on a scene description task of three visually presented scenes	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 assessment in the performance on a picture naming task	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 post-treatment in the performance on the picture naming task at 3 months post-therapy	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 in the scene description task at 3 months post-therapy	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	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 at 3 months post-therapy	Pre-treatment and 3 months follow-up	Total number of correctly generated items such as animals, fruits, clothes.

Secondary Outcome Measures

Name	Time	Method
Modified Communication Effectiveness Index (CETI)	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.

Trial Locations

Locations (1)

Institute of Psychiatry and Neurology; 🇵🇱 Warsaw, Masovian Voivodeship, Poland