Speech Entrainment for Aphasia Recovery

Study Overview
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Brief Summary
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After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. The study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production. Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).

Official Title
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Speech Entrainment for Aphasia Recovery

Conditions
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Aphasia, Aphasia Non Fluent, Stroke

Intervention / Treatment
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* Behavioral: SET (Speech Entrainment Therapy) 3 weeks
* Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks
* Behavioral: SET (Speech Entrainment Therapy) 6 weeks
* Other: No Therapy 6 Weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Aphasia as a result of a left hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient <93.8). Presence of left hemisphere stroke in clinical imaging (CT/MRI) and NIHSS Participants must have spoken English as their primary language. 21-81 years old Pre-stroke modified Rankin Scale (mRS)= 2 or less Post-stroke mRS= 4 or less. At least 6 months post-stroke. Non-fluent aphasia (WAB-R Comprehension score >4 and WAB-R Fluency score <6). Technological compatibility (to be determined by clinical judgment of SLP) Exclusion Criteria History of chronic neurological or psychiatric diseases (excluding migraines, depression, or post-stroke epilepsy). Self-reported history of learning disability. Severe dysarthria (determined via SLP clinical judgment from spontaneous speech tasks on the ASRS 3.0). Global aphasia. History of right-hemisphere strokes or brain stem/cerebellar strokes with persistent deficits (as evidenced by MRI/CT and NIHSS). Uncorrectable hearing as determined by the SLP's clinical judgment. Uncorrectable vision. Contraindications to MRI or inability to complete the MRI scanning session. Women who are pregnant.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SET (Speech Entrainment Therapy) 3 weeks<br> | Behavioral: SET (Speech Entrainment Therapy) 3 weeks<br>* 3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program<br>|
| Experimental: SET (Speech Entrainment Therapy) 4.5 weeks<br> | Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks<br>* 4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program<br>|
| Experimental: SET (Speech Entrainment Therapy) 6 weeks<br> | Behavioral: SET (Speech Entrainment Therapy) 6 weeks<br>* 6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program<br>|
| Other: No Therapy 6 weeks<br> | Other: No Therapy 6 Weeks<br>* Participants will not be getting any SET for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Verbs Per Minute (VPM) in Speech Sample | VPM will be assessed through procedural storytelling and narrative story telling tasks - with four items in each category. The procedural storytelling items are: 1) how to make a peanut butter and jelly sandwich, 2) how to make scrambled eggs, 3) how to brew coffee, and 4) how to wash dishes. The narrative items will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks. | 3 months after treatment (or no treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) | We will estimate the dose of SET for individuals with non-fluent aphasia that has the highest effect size on SAQOL-39g. | 3 months after treatment (or no treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphasia, Speech Language Pathology, Therapy