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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901156
• Other study ID #: REB17-1014
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Aphasia, Non-fluent
• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & 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 randomize — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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