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

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT04901156

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Aphasia, Non-fluent	Device: 1Hz inhibitory rTMS Behavioral: Multi-Modality Aphasia Therapy (M-MAT) Device: 1Hz sham rTMS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

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.

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)

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.

Outcome Measures

Primary Outcome Measures

Change from baseline on the Boston Naming Test within one week of intervention completion [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 [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.

Secondary Outcome Measures

Trained and Untrained Picture Naming [Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up]
Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs
Story Narrative Task [Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up]
Retelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.
Patient Health Questionnaire (PHQ-9) [Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up]
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 [Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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