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rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia (TMAT)

Primary Purpose

Stroke, Aphasia, Non-fluent

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
1Hz inhibitory rTMS
Multi-Modality Aphasia Therapy (M-MAT)
1Hz sham rTMS
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

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, Stroke, Aphasia, Aphasia, Broca, Speech Disorders, Language Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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.

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%.

Outcomes

Primary Outcome Measures

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.
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.

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
Story Narrative Task
Retelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.
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.
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.

Full Information

First Posted
May 20, 2021
Last Updated
September 11, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04901156
Brief Title
rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia
Acronym
TMAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (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, Stroke, Aphasia, Aphasia, Broca, Speech Disorders, Language Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-modality aphasia therapy plus 1Hz rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi-modality aphasia therapy plus sham rTMS
Arm Type
Sham Comparator
Arm Description
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%.
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
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.
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.
Primary Outcome Measure Information:
Title
Change from baseline on the Boston Naming Test within one week of intervention completion
Description
Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.
Time Frame
Baseline, within 1 week of completing the 10 day intervention
Title
Change from baseline on the Boston Naming Test at 3 months
Description
Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.
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
Story Narrative Task
Description
Retelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up
Title
EuroQoL-5D-5L
Description
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.
Time Frame
Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

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 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
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
Citations:
PubMed Identifier
36525719
Citation
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.
Results Reference
result

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rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia

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