Clinical trial NCT04901156: rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia
Official title: A Randomized Pilot Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modality 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
Stroke
Aphasia
Aphasia, Broca
Speech Disorders
Language Disorders
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 more than 6 months ago (chronic)
* Stroke type: Ischemic or hemorrhagic
* Non-fluent aphasia as determined by the Western Aphasia Battery (Fluency \< 5)
* Right-hand dominant prior to stroke
* 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 Boston Naming Test within one week of intervention completion
timeFrame: Baseline, within 1 week of completing the 10 day intervention
measure: Change from baseline on the Boston Naming Test 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: Story Narrative Task
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
measure: EuroQoL-5D-5L
timeFrame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
References:
citation: Low TA, Lindland K, Kirton A, Carlson HL, Harris AD, Goodyear BG, Monchi O, Hill MD, Dukelow SP. Repetitive transcranial magnetic stimulation (rTMS) combined with multi-modality aphasia therapy for chronic post-stroke non-fluent aphasia: A pilot randomized sham-controlled trial. Brain Lang. 2023 Jan;236:105216. doi: 10.1016/j.bandl.2022.105216. Epub 2022 Dec 14.