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rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia

A Randomized Pilot Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modality Aphasia Treatment (M-MAT) for Post-Stroke Non-Fluent Aphasia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04901156
Acronym
TMAT
Enrollment
20
Registered
2021-05-25
Start date
2018-04-01
Completion date
2020-01-31
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Non-fluent, Stroke

Keywords

Non-invasive brain stimulation, Transcranial Magnetic Stimulation, Multi-modality aphasia therapy, Neuroimaging, Stroke, Aphasia, Aphasia, Broca, Speech Disorders, Language Disorders

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.

Interventions

20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil

Participants receive 3.5 hours of intensive speech therapy in small groups delivered by a blinded speech language pathologist and therapy assistant. The objective of M-MAT is to improve word production through shaping of responses (ie. Gradually increasing complexity of spoken targets towards eventual mastery) and social-mediated repetitive practice. Therapists use game-based interactive tasks and rich multi-modal cueing (gestures, written words, drawing, reading words) to improve spoken production and oral communication.

20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 sham coil.

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline on the Boston Naming Test within one week of intervention completionBaseline, within 1 week of completing the 10 day interventionNumber of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.
Change from baseline on the Boston Naming Test at 3 monthsBaseline and 3-month follow-upNumber of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.

Secondary

MeasureTime frameDescription
Trained and Untrained Picture NamingBaseline, within 1 week of completing the 10 day intervention and 3-month follow-upNumber of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs
Story Narrative TaskBaseline, within 1 week of completing the 10 day intervention and 3-month follow-upRetelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.
Patient Health Questionnaire (PHQ-9)Baseline, within 1 week of completing the 10 day intervention and 3-month follow-upA 9-item questionnaire completed by a caregiver to quickly assess depressive symptoms. The scale ranges from 0 to 27 with higher scores indicating greater endorsement of depressive symptoms.
EuroQoL-5D-5LBaseline, within 1 week of completing the 10 day intervention and 3-month follow-upAssesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given can be converted into EQ-5D index with scores anchored at 0 for death and 1 for perfect health. The EQ-5D also records the patient's self-rated health on a vertical visual analogue scale ranging from 0 to 100 with higher scores indicating higher self-perceived quality of life. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026