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Completed

NCT Number: NCT04901156

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1Hz inhibitory rTMS

Device

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

Multi-Modality Aphasia Therapy (M-MAT)

Behavioral

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.

1Hz sham rTMS

Device

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.

Primary outcomes

  1. Change from baseline on the Boston Naming Test within one week of intervention completion

    Time frame: Baseline, within 1 week of completing the 10 day intervention

    Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.

  2. Change from baseline on the Boston Naming Test at 3 months

    Time frame: Baseline and 3-month follow-up

    Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.

Secondary outcomes

  1. Trained and Untrained Picture Naming

    Time frame: 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

  2. Story Narrative Task

    Time frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

    Retelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

    A 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.

  4. EuroQoL-5D-5L

    Time frame: 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 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: TMAT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 25, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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