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NCT Number: NCT04102228

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

Conditions

Stroke Aphasia Aphasia, Broca Aphasia, Non-fluent Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

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 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

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

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.

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.

Primary outcomes

  1. Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion

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

    Western Aphasia Battery Aphasia quotient (WAB-AQ) composite score, composed of fluency, spontaneous speech, naming, and comprehension sub-tests. Scores range from 0 to 100, with higher scores indicating better overall speech and language abilities. Positive change from baseline indicates better outcome.

  2. Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient at 3 months

    Time frame: Baseline and 3-month follow-up

    Western Aphasia Battery Aphasia quotient (WAB-AQ) composite score, composed of fluency, spontaneous speech, naming, and comprehension sub-tests. Scores range from 0 to 100, with higher scores indicating better overall speech and language abilities. Positive change from baseline indicates better outcome.

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. Scenario Test (UK)

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

    Test of functional communication based on everyday conversational scenarios

  3. Connected speech sample

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

    Records the number of correct information units provided by participants while re-telling a familiar story (e.g., the three little pigs)

  4. Cognitive Linguistic Quick Test - aphasia administration

    Time frame: Baseline

    Brief assessment of non-verbal cognition

  5. Overt Naming Functional Magnetic Resonance Imaging

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

    Functional neuroimaging collected during picture naming task to assess activity associated with naming

  6. Resting-state Functional Magnetic Resonance Imaging

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

    Functional neuroimaging collected during rest to be used for functional connectivity

  7. Magnetic Resonance Spectroscopy

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

    1H proton spectroscopy used to measure metabolite concentrations within the right inferior frontal gyrus

  8. Diffusion weighted Magnetic Resonance Imaging

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

    Neuroimaging measuring the diffusion of water to be used for white matter reconstruction

  9. Communication Effectiveness Index

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

    Caregiver completed questionnaire to assess functional communication

  10. Stroke Aphasic Depression Questionnaire (SADQ)

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

    A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia.

  11. Stroke and Aphasia Quality of Life Scale (SAQOL)

    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 EQ also records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  12. Western Aphasia Battery - Bedside (WAB)

    Time frame: Screening appointment

    Assesses the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia.

  13. Apraxia Battery for Adults (ABA)

    Time frame: Screening appointment

    Assesses characteristics of verbal apraxia

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study 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

Acronym: REMAP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2019
Registry last updated
Aug 12, 2024

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

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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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