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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia, Non-fluent
• Intervention / Treatment: Device: 1Hz inhibitory rTMS; Behavioral: Multi-Modality Aphasia Therapy (M-MAT); Device: 1Hz sham rTMS

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-modality aphasia therapy plus 1Hz rTMS; 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.	Device: 1Hz inhibitory rTMS; 20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil; Behavioral: 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.
Sham Comparator: Multi-modality aphasia therapy plus sham rTMS; 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%.	Behavioral: 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.; Device: 1Hz sham rTMS; 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 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.	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.	Baseline and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trained and Untrained Picture Naming	Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs	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.	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.	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.	Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Calgary

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Transcranial Magnetic Stimulation; Aphasia; Neuroimaging; Speech Disorders; Non-invasive brain stimulation; Language Disorders; Multi-modality aphasia therapy; Aphasia, Broca
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia; Aphasia, Broca
• Other Study ID Numbers: REB17-1014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make IPD available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No