Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia
- Conditions
- StrokeAphasia, Non-fluent
- Interventions
- Device: 1Hz inhibitory rTMSDevice: 1Hz sham rTMSBehavioral: Multi-Modality Aphasia Therapy (M-MAT)
- Registration Number
- NCT04102228
- Lead Sponsor
- University of Calgary
- Brief Summary
Many stroke survivors experience aphasia, a loss or impairment of language affecting the production or understanding of speech. One common type of aphasia is known as non-fluent aphasia. Patients with non-fluent aphasia have difficulty formulating grammatical sentences, often producing short word fragments despite having a good understanding of what others are trying to communicate to them. Speech language pathologists (SLPs) play a central role rehabilitating persons with aphasia and administer therapy in an attempt to improve communication skills. Despite standard therapy, approximately 50% of individuals who experience aphasia acutely continue to have language deficits more than 6 months post-stroke.
In most people, Broca's area is dominant in the left side of the brain. Following a left-sided stroke, the right-sided homologue of Broca's area (the pars triangularis), may adopt language function. Unfortunately, reorganizing language to the right side of the brain seems to be less effective than restoring function to the left hemisphere. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, can be used to suppress activity of specific regions in the right side of the brain to promote recovery of function in the perilesional area. Despite preliminary success in existing studies using rTMS in post-stroke aphasia, there is much work to be done to better understand the mechanisms underlying recovery. Responses to rTMS have been positive, yet heterogenous, which may be related to timing of treatments following stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Isolated left middle cerebral artery (MCA) stroke within past 6 months (sub-acute) or more than 6 months ago (chronic)
- Stroke type: Ischemic or hemorrhagic
- Non-fluent aphasia as determined by the Western Aphasia Battery (Fluency < 5)
- English is first or primary language
- Ability to follow 3-step commands
- Prior stroke to the right frontal lobe
- Current diagnosis of moderate to severe depression
- Diagnosis of any other psychiatric condition
- History of other neurologic disorders (e.g., epilepsy, brain tumor)
- Contraindication to MRI or TMS (metal in the head or any implanted electrical device)
- Has received intensive speech therapy within the past 6 months (>8 hours per week)
- Enrolled in another interventional study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-modality aphasia therapy plus sham rTMS Multi-Modality Aphasia Therapy (M-MAT) Participants receive 10 days of 3.5hrs of multi-modality aphasia therapy (M-MAT) preceded by 20 minutes of sham rTMS is achieved using a sham TMS coil which attenuates the magnetic output of the stimulator by 80%. Multi-modality aphasia therapy plus 1Hz rTMS 1Hz inhibitory rTMS Participants receive 10 days of 3.5hrs of multi-modality aphasia therapy (M-MAT) preceded by 20 minutes of 1Hz rTMS delivered at 100% of resting motor threshold over the right pars triangularis. Multi-modality aphasia therapy plus 1Hz rTMS Multi-Modality Aphasia Therapy (M-MAT) Participants receive 10 days of 3.5hrs of multi-modality aphasia therapy (M-MAT) preceded by 20 minutes of 1Hz rTMS delivered at 100% of resting motor threshold over the right pars triangularis. Multi-modality aphasia therapy plus sham rTMS 1Hz sham rTMS Participants receive 10 days of 3.5hrs of multi-modality aphasia therapy (M-MAT) preceded by 20 minutes of sham rTMS is achieved using a sham TMS coil which attenuates the magnetic output of the stimulator by 80%.
- Primary Outcome Measures
Name Time Method Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion Baseline, within 1 week of completing the 10 day intervention Western Aphasia Battery Aphasia quotient (WAB-AQ) composite score, composed of fluency, spontaneous speech, naming, and comprehension sub-tests. Scores range from 0 to 100, with higher scores indicating better overall speech and language abilities. Positive change from baseline indicates better outcome.
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient at 3 months Baseline and 3-month follow-up Western Aphasia Battery Aphasia quotient (WAB-AQ) composite score, composed of fluency, spontaneous speech, naming, and comprehension sub-tests. Scores range from 0 to 100, with higher scores indicating better overall speech and language abilities. Positive change from baseline indicates better outcome.
- Secondary Outcome Measures
Name Time Method Scenario Test (UK) Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Test of functional communication based on everyday conversational scenarios
Connected speech sample Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Records the number of correct information units provided by participants while re-telling a familiar story (e.g., the three little pigs)
Cognitive Linguistic Quick Test - aphasia administration Baseline Brief assessment of non-verbal cognition
Resting-state Functional Magnetic Resonance Imaging Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Functional neuroimaging collected during rest to be used for functional connectivity
Stroke Aphasic Depression Questionnaire (SADQ) Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia.
Stroke and Aphasia Quality of Life Scale (SAQOL) Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ also records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Western Aphasia Battery - Bedside (WAB) Screening appointment Assesses the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia.
Trained and Untrained Picture Naming Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs.
Overt Naming Functional Magnetic Resonance Imaging Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Functional neuroimaging collected during picture naming task to assess activity associated with naming
Magnetic Resonance Spectroscopy Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up 1H proton spectroscopy used to measure metabolite concentrations within the right inferior frontal gyrus
Diffusion weighted Magnetic Resonance Imaging Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Neuroimaging measuring the diffusion of water to be used for white matter reconstruction
Communication Effectiveness Index Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up Caregiver completed questionnaire to assess functional communication
Apraxia Battery for Adults (ABA) Screening appointment Assesses characteristics of verbal apraxia
Trial Locations
- Locations (1)
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada