Clinical trial NCT04102228: Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia
Official title: A Randomized Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modal Aphasia Treatment (M-MAT) for Post-Stroke Non-Fluent Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia, Non-fluent
Keywords: Non-invasive brain stimulation
Transcranial Magnetic Stimulation
Multi-modality aphasia therapy
Neuroimaging
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups for the duration of the study (Multi-modality aphasia therapy plus inhibitory rTMS or multi-modality aphasia therapy plus sham rTMS).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion
timeFrame: Baseline, within 1 week of completing the 10 day intervention
measure: Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient at 3 months
timeFrame: Baseline and 3-month follow-up
Secondary outcomes:
measure: Trained and Untrained Picture Naming
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Scenario Test (UK)
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Connected speech sample
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Cognitive Linguistic Quick Test - aphasia administration
timeFrame: Baseline
measure: Overt Naming Functional Magnetic Resonance Imaging
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Resting-state Functional Magnetic Resonance Imaging
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Magnetic Resonance Spectroscopy
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Diffusion weighted Magnetic Resonance Imaging
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Communication Effectiveness Index
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Stroke Aphasic Depression Questionnaire (SADQ)
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Stroke and Aphasia Quality of Life Scale (SAQOL)
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Western Aphasia Battery - Bedside (WAB)
timeFrame: Screening appointment
measure: Apraxia Battery for Adults (ABA)
timeFrame: Screening appointment
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sean P Dukelow, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: