Speech Entrainment for Aphasia Recovery

Stroke Clinical Trial

— SpARc  

Official title:

Speech Entrainment for Aphasia Recovery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04364854
• Other study ID #: 00091924
• Secondary ID: U01DC017521-01A1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 21, 2020
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: October 1, 2025
• Est. primary completion date: May 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 81 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Aphasia Non Fluent
• Stroke

Intervention

Behavioral:
• 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
• 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
• 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

Other:
• No Therapy 6 Weeks
Participants will not be getting any SET for 6 weeks

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of South Carolina	Columbia	South Carolina
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)