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

NCT04901156 | Completed

• 1 other identifier: REB17-1014
• Study Type: interventional
• Target: 20
• 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; Stroke; Aphasia; Aphasia, Broca; Speech Disorders; Language Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Trained and Untrained Picture Naming

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

• Story Narrative Task

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

• Patient Health Questionnaire (PHQ-9)

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

• EuroQoL-5D-5L

  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

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; 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%.

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

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

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

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

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 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

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, 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.

  PMID: 36525719 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: April 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)