Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia (REMAP)
Primary Purpose
Stroke, Aphasia, Non-fluent
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
1Hz inhibitory rTMS
1Hz sham rTMS
Multi-Modality Aphasia Therapy (M-MAT)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Non-invasive brain stimulation, Transcranial Magnetic Stimulation, Multi-modality aphasia therapy, Neuroimaging
Eligibility Criteria
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
Sites / Locations
- Foothills Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Multi-modality aphasia therapy plus 1Hz rTMS
Multi-modality aphasia therapy plus sham rTMS
Arm Description
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.
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%.
Outcomes
Primary Outcome Measures
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion
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
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 Outcome Measures
Trained and Untrained Picture Naming
Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs.
Scenario Test (UK)
Test of functional communication based on everyday conversational scenarios
Connected speech sample
Records the number of correct information units provided by participants while re-telling a familiar story (e.g., the three little pigs)
Cognitive Linguistic Quick Test - aphasia administration
Brief assessment of non-verbal cognition
Overt Naming Functional Magnetic Resonance Imaging
Functional neuroimaging collected during picture naming task to assess activity associated with naming
Resting-state Functional Magnetic Resonance Imaging
Functional neuroimaging collected during rest to be used for functional connectivity
Magnetic Resonance Spectroscopy
1H proton spectroscopy used to measure metabolite concentrations within the right inferior frontal gyrus
Diffusion weighted Magnetic Resonance Imaging
Neuroimaging measuring the diffusion of water to be used for white matter reconstruction
Communication Effectiveness Index
Caregiver completed questionnaire to assess functional communication
Stroke Aphasic Depression Questionnaire (SADQ)
A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia.
Stroke and Aphasia Quality of Life Scale (SAQOL)
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.
Western Aphasia Battery - Bedside (WAB)
Assesses the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia.
Apraxia Battery for Adults (ABA)
Assesses characteristics of verbal apraxia
Full Information
NCT ID
NCT04102228
First Posted
September 20, 2019
Last Updated
October 5, 2023
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT04102228
Brief Title
Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia
Acronym
REMAP
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
August 21, 2023 (Actual)
Study Completion Date
August 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia, Non-fluent
Keywords
Non-invasive brain stimulation, Transcranial Magnetic Stimulation, Multi-modality aphasia therapy, Neuroimaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups for the duration of the study (Multi-modality aphasia therapy plus inhibitory rTMS or multi-modality aphasia therapy plus sham rTMS).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-modality aphasia therapy plus 1Hz rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi-modality aphasia therapy plus sham rTMS
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
1Hz inhibitory rTMS
Intervention Description
20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil
Intervention Type
Device
Intervention Name(s)
1Hz sham rTMS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-Modality Aphasia Therapy (M-MAT)
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient within one week of intervention completion
Description
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.
Time Frame
Baseline, within 1 week of completing the 10 day intervention
Title
Change from baseline on the Western Aphasia Battery (Revised) Aphasia Quotient at 3 months
Description
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.
Time Frame
Baseline and 3-month follow-up
Secondary Outcome Measure Information:
Title
Trained and Untrained Picture Naming
Description
Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs.
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Scenario Test (UK)
Description
Test of functional communication based on everyday conversational scenarios
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Connected speech sample
Description
Records the number of correct information units provided by participants while re-telling a familiar story (e.g., the three little pigs)
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Cognitive Linguistic Quick Test - aphasia administration
Description
Brief assessment of non-verbal cognition
Time Frame
Baseline
Title
Overt Naming Functional Magnetic Resonance Imaging
Description
Functional neuroimaging collected during picture naming task to assess activity associated with naming
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Resting-state Functional Magnetic Resonance Imaging
Description
Functional neuroimaging collected during rest to be used for functional connectivity
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Magnetic Resonance Spectroscopy
Description
1H proton spectroscopy used to measure metabolite concentrations within the right inferior frontal gyrus
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Diffusion weighted Magnetic Resonance Imaging
Description
Neuroimaging measuring the diffusion of water to be used for white matter reconstruction
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Communication Effectiveness Index
Description
Caregiver completed questionnaire to assess functional communication
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Stroke Aphasic Depression Questionnaire (SADQ)
Description
A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia.
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Stroke and Aphasia Quality of Life Scale (SAQOL)
Description
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.
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Western Aphasia Battery - Bedside (WAB)
Description
Assesses the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia.
Time Frame
Screening appointment
Title
Apraxia Battery for Adults (ABA)
Description
Assesses characteristics of verbal apraxia
Time Frame
Screening appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean P Dukelow, MD PhD FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make IPD available to other researchers
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia
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