Speech Entrainment for Aphasia Recovery (SpARc)

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Aphasia Non Fluent; Stroke; Aphasia

Treatments: Behavioral: SET (Speech Entrainment Therapy) 6 weeks; Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks; Other: No Therapy 6 Weeks; Behavioral: SET (Speech Entrainment Therapy) 3 weeks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04364854

00091924

U01DC017521-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 21 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

SET (Speech Entrainment Therapy) 3 weeks

Experimental group

Treatment:

Behavioral: SET (Speech Entrainment Therapy) 3 weeks

SET (Speech Entrainment Therapy) 4.5 weeks

Experimental group

Treatment:

Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks

SET (Speech Entrainment Therapy) 6 weeks

Experimental group

Treatment:

Behavioral: SET (Speech Entrainment Therapy) 6 weeks

No Therapy 6 weeks

Other group

Treatment:

Other: No Therapy 6 Weeks