Speech Entrainment for Aphasia Recovery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-21

Study Completion Date

2025-08-31

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).

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Detailed Description

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Conditions

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Aphasia Aphasia Non Fluent Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SET (Speech Entrainment Therapy) 3 weeks

Group Type EXPERIMENTAL

SET (Speech Entrainment Therapy) 3 weeks

Intervention Type BEHAVIORAL

3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

SET (Speech Entrainment Therapy) 4.5 weeks

Group Type EXPERIMENTAL

SET (Speech Entrainment Therapy) 4.5 weeks

Intervention Type BEHAVIORAL

4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

SET (Speech Entrainment Therapy) 6 weeks

Group Type EXPERIMENTAL

SET (Speech Entrainment Therapy) 6 weeks

Intervention Type BEHAVIORAL

6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

No Therapy 6 weeks

Group Type OTHER

No Therapy 6 Weeks

Intervention Type OTHER

Participants will not be getting any SET for 6 weeks

Interventions

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SET (Speech Entrainment Therapy) 3 weeks

3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

Intervention Type BEHAVIORAL

SET (Speech Entrainment Therapy) 4.5 weeks

4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

Intervention Type BEHAVIORAL

SET (Speech Entrainment Therapy) 6 weeks

6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

Intervention Type BEHAVIORAL

No Therapy 6 Weeks

Participants will not be getting any SET for 6 weeks

Intervention Type OTHER

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No