Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia

NCT04102228 | Completed

• 1 other identifier: REB19-0829
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Aphasia, Non-fluent

Keywords

Non-invasive brain stimulation; Transcranial Magnetic Stimulation; Multi-modality aphasia therapy; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, within 1 week of completing the 10 day intervention

• 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.

  Baseline and 3-month follow-up

Secondary Outcomes (13)

• Trained and Untrained Picture Naming

  Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

• Scenario Test (UK)

  Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

• Connected speech sample

  Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

• Cognitive Linguistic Quick Test - aphasia administration

  Baseline

• Overt Naming Functional Magnetic Resonance Imaging

  Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up

Study Arms (2)

Multi-modality aphasia therapy plus 1Hz rTMS

EXPERIMENTAL

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.

Device: 1Hz inhibitory rTMS; Behavioral: Multi-Modality Aphasia Therapy (M-MAT)

Multi-modality aphasia therapy plus sham rTMS

SHAM COMPARATOR

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%.

Device: 1Hz sham rTMS; Behavioral: Multi-Modality Aphasia Therapy (M-MAT)

Interventions

1Hz inhibitory rTMS DEVICE

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 plus 1Hz rTMS

1Hz sham rTMS DEVICE

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.

Multi-modality aphasia therapy plus sham rTMS

Multi-Modality Aphasia Therapy (M-MAT) BEHAVIORAL

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.

Multi-modality aphasia therapy plus 1Hz rTMS; Multi-modality aphasia therapy plus sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

• Low TA, Lindland K, Kirton A, Carlson HL, Harris AD, Goodyear BG, Monchi O, Hill MD, Rose ML, Dukelow SP. Transcranial Magnetic Stimulation Combined With Multimodality Aphasia Therapy for Chronic Poststroke Aphasia: A Randomized Clinical Trial. Neurology. 2025 Mar 25;104(6):e213424. doi: 10.1212/WNL.0000000000213424. Epub 2025 Feb 25.

  PMID: 39999397 DERIVED

MeSH Terms

Conditions

Stroke; Aphasia, Broca

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean P Dukelow, MD PhD FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: April 15, 2021
• Primary Completion: August 21, 2023
• Study Completion: August 24, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)