StrokeTMATNCT04901156
rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia
A study testing 1Hz inhibitory rTMS and Multi-Modality Aphasia Therapy (M-MAT) in people with Stroke and Aphasia, Non-fluent, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Aphasia, Non-fluent
- What is being tested?
- 1Hz inhibitory rTMS and Multi-Modality Aphasia Therapy (M-MAT)
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pilot Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modality 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.
- Conditions
- Stroke, Aphasia, Non-fluent
- Being tested
- 1Hz inhibitory rTMS, Multi-Modality Aphasia Therapy (M-MAT), 1Hz sham rTMS
- Keywords
- Non-invasive brain stimulation, Transcranial Magnetic Stimulation, Multi-modality aphasia therapy, Neuroimaging, Stroke, Aphasia, Aphasia, Broca, Speech Disorders, Language Disorders
- Medical subject headings
- Stroke, Aphasia, Broca, Aphasia, Speech Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1Hz inhibitory rTMSDevice
20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil
Multi-Modality Aphasia Therapy (M-MAT)Behavioural
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.
1Hz sham rTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-modality aphasia therapy plus 1Hz rTMS | Experimental | Chronic stroke patients, 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. Receives: Device: 1Hz inhibitory rTMS; Behavioral: Multi-Modality Aphasia Therapy (M-MAT) |
| Multi-modality aphasia therapy plus sham rTMS | Sham comparator | Chronic stroke patients, 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%. Receives: Behavioral: Multi-Modality Aphasia Therapy (M-MAT); Device: 1Hz sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Boston Naming Test within one week of intervention completion
Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.
Measured: Baseline, within 1 week of completing the 10 day intervention
Change from baseline on the Boston Naming Test at 3 months
Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.
Measured: Baseline and 3-month follow-up
Secondary outcomes (4)
Trained and Untrained Picture Naming
Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs
Measured: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Story Narrative Task
Retelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.
Measured: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Patient Health Questionnaire (PHQ-9)
A 9-item questionnaire completed by a caregiver to quickly assess depressive symptoms. The scale ranges from 0 to 27 with higher scores indicating greater endorsement of depressive symptoms.
Measured: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
EuroQoL-5D-5L
Assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given can be converted into EQ-5D index with scores anchored at 0 for death and 1 for perfect health. The EQ-5D also records the patient's self-rated health on a vertical visual analogue scale ranging from 0 to 100 with higher scores indicating higher self-perceived quality of life. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Apr 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sean Dukelow, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901156
- Sponsor's protocol ID
- REB17-1014
- Acronym
- TMAT
- Status last verified
- Sep 2023
- First submitted
- 20 May 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available to other researchers
Publications
Low TA, Lindland K, Kirton A, Carlson HL, Harris AD, Goodyear BG, Monchi O, Hill MD, Dukelow SP. Repetitive transcranial magnetic stimulation (rTMS) combined with multi-modality aphasia therapy for chronic post-stroke non-fluent aphasia: A pilot randomized sham-controlled trial. Brain Lang. 2023 Jan;236:105216. doi: 10.1016/j.bandl.2022.105216. Epub 2022 Dec 14.
PubMed 36525719
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modality Aphasia Treatment (M-MAT) for Post-Stroke Non-Fluent Aphasia
- ClinicalTrials.gov ID
- NCT04901156
- Acronym / sponsor ID
- TMAT / REB17-1014
- Conditions
- Stroke, Aphasia, Non-fluent
- Keywords
- Non-invasive brain stimulation, Transcranial Magnetic Stimulation, Multi-modality aphasia therapy, Neuroimaging, Stroke, Aphasia, Aphasia, Broca, Speech Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-modality aphasia therapy plus 1Hz rTMS | Experimental | Device: 1Hz inhibitory rTMS, Behavioral: Multi-Modality Aphasia Therapy (M-MAT)Chronic stroke patients, 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. |
| Multi-modality aphasia therapy plus sham rTMS | Sham comparator | Behavioral: Multi-Modality Aphasia Therapy (M-MAT), Device: 1Hz sham rTMSChronic stroke patients, 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%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1Hz inhibitory rTMS20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil | Device | Multi-modality aphasia therapy plus 1Hz rTMS |
| Multi-Modality Aphasia Therapy (M-MAT)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. | Behavioural | Multi-modality aphasia therapy plus 1Hz rTMS, Multi-modality aphasia therapy plus sham rTMS |
| 1Hz sham rTMS20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 sham coil. | Device | Multi-modality aphasia therapy plus sham rTMS |
Primary outcome
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.
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.
4 secondary outcomes
Trained and Untrained Picture Naming
Time frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Story Narrative Task
Time frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
EuroQoL-5D-5L
Time frame: Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Results publication: PubMed 36525719Low TA, Lindland K, Kirton A, Carlson HL, Harris AD, Goodyear BG, Monchi O, Hill MD, Dukelow SP. Repetitive transcranial magnetic stimulation (rTMS) combined with multi-modality aphasia therapy for chronic post-stroke non-fluent aphasia: A pilot randomized sham-controlled trial. Brain Lang. 2023 Jan;236:105216. doi: 10.1016/j.bandl.2022.105216. Epub 2022 Dec 14.
- Individual participant dataSharing planned: No. No plan to make IPD available to other researchers
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1Hz inhibitory rTMS and Multi-Modality Aphasia Therapy (M-MAT) in people with Stroke and Aphasia, Non-fluent, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.