Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Psychiatry and Neurology, Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Noninvasive transcranial brain stimulation: excitatory iTBS
Device600 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 cTBS
Device600 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)
Behavioral45 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
DeviceSham TMS coil positioned exactly like an active TMS coil resulting in a very good approximation of the auditory effects Device: Magstim Co., Wales, UK.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapyExperimental treatment 2 interventions
Group B: Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapyExperimental treatment 2 interventions
Group C: Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapySham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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) assessment3
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 assessment4
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)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.
Time frame
Pre-treatment, post-treatment (within 2 days of completing the 15 day intervention) and on 3-month follow-upOther outcomes
1
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)Sponsors and contacts
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Source ClinicalTrials.gov