Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia (REMAP)

University of Calgary

Status: Completed

Conditions: Stroke; Aphasia, Non-fluent

Treatments: Device: 1Hz inhibitory rTMS; Device: 1Hz sham rTMS; Behavioral: Multi-Modality Aphasia Therapy (M-MAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04102228

REB19-0829

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

Multi-modality aphasia therapy plus 1Hz rTMS

Experimental group

Description:

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.

Treatment:

Behavioral: Multi-Modality Aphasia Therapy (M-MAT)

Device: 1Hz inhibitory rTMS

Multi-modality aphasia therapy plus sham rTMS

Sham Comparator group

Description:

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%.

Treatment:

Behavioral: Multi-Modality Aphasia Therapy (M-MAT)

Device: 1Hz sham rTMS