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Clinical Trials/NCT04102228
NCT04102228CompletedNot Applicable

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

University of Calgary1 site in 1 country46 target enrollmentStarted: April 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Multi-modality aphasia therapy plus 1Hz rTMS

Experimental

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.

Intervention: 1Hz inhibitory rTMS (Device)

Multi-modality aphasia therapy plus 1Hz rTMS

Experimental

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.

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

Multi-modality aphasia therapy plus sham rTMS

Sham Comparator

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%.

Intervention: 1Hz sham rTMS (Device)

Multi-modality aphasia therapy plus sham rTMS

Sham Comparator

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%.

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

Outcomes

Primary Outcomes

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.

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

  • Scenario Test (UK)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Connected speech sample(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Cognitive Linguistic Quick Test - aphasia administration(Baseline)
  • Resting-state Functional Magnetic Resonance Imaging(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Stroke Aphasic Depression Questionnaire (SADQ)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Stroke and Aphasia Quality of Life Scale (SAQOL)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Western Aphasia Battery - Bedside (WAB)(Screening appointment)
  • Trained and Untrained Picture Naming(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Overt Naming Functional Magnetic Resonance Imaging(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Magnetic Resonance Spectroscopy(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Diffusion weighted Magnetic Resonance Imaging(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Communication Effectiveness Index(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Apraxia Battery for Adults (ABA)(Screening appointment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Sean Dukelow

Associate Professor

University of Calgary

Study Sites (1)

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