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Clinical Trials/NCT04901156
NCT04901156
Completed
Not Applicable

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

University of Calgary1 site in 1 country20 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Calgary
Enrollment
20
Locations
1
Primary Endpoint
Change from baseline on the Boston Naming Test at 3 months
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
January 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Sean Dukelow

Associate Professor

University of Calgary

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Trained and Untrained Picture Naming(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Story Narrative Task(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Patient Health Questionnaire (PHQ-9)(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)
  • EuroQoL-5D-5L(Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up)

Study Sites (1)

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