- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102228
Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia (REMAP)
A Randomized Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modal Aphasia Treatment (M-MAT) 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Trevor A Low, BSc
- Phone Number: 4039448461
- Email: talow@ucalgary.ca
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multi-modality aphasia therapy plus 1Hz rTMS
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.
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20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil
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.
|
Sham Comparator: Multi-modality aphasia therapy plus sham rTMS
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%.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, within 1 week of completing the 10 day intervention
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Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient at 3 months
Time Frame: Baseline and 3-month follow-up
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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.
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Baseline and 3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trained and Untrained Picture Naming
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs.
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Scenario Test (UK)
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Test of functional communication based on everyday conversational scenarios
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Connected speech sample
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Records the number of correct information units provided by participants while re-telling a familiar story (e.g., the three little pigs)
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Cognitive Linguistic Quick Test - aphasia administration
Time Frame: Baseline
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Brief assessment of non-verbal cognition
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Baseline
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Overt Naming Functional Magnetic Resonance Imaging
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Functional neuroimaging collected during picture naming task to assess activity associated with naming
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Resting-state Functional Magnetic Resonance Imaging
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Functional neuroimaging collected during rest to be used for functional connectivity
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Magnetic Resonance Spectroscopy
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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1H proton spectroscopy used to measure metabolite concentrations within the right inferior frontal gyrus
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Diffusion weighted Magnetic Resonance Imaging
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Neuroimaging measuring the diffusion of water to be used for white matter reconstruction
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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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
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Stroke Aphasic Depression Questionnaire (SADQ)
Time Frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia.
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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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
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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.
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Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
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Western Aphasia Battery - Bedside (WAB)
Time Frame: Screening appointment
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Assesses the linguistic skills and main nonlinguistic skills of adults with aphasia.
This provides information for the diagnosis of the type of aphasia.
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Screening appointment
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Apraxia Battery for Adults (ABA)
Time Frame: Screening appointment
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Assesses characteristics of verbal apraxia
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Screening appointment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sean P Dukelow, MD PhD FRCPC, University of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB19-0829
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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