Phase 2 N=80 Randomized Single-blind Treatment

Speech Entrainment for Aphasia Recovery

Aphasia · Aphasia Non Fluent · Stroke

Bottom Line

View on ClinicalTrials.gov: NCT04364854 ↗

Enrolled (actual)

Serious AEs

7.5%

Results posted

Apr 2025

Primary outcome: Primary: Average Verbs Per Minute (VPM) Change From Baseline — 0.3; 0.62; -0.26; 0.52 verbs per minute

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SET (Speech Entrainment Therapy) 3 weeks (Behavioral); SET (Speech Entrainment Therapy) 4.5 weeks (Behavioral); SET (Speech Entrainment Therapy) 6 weeks (Behavioral); No Therapy 6 Weeks (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Verbs Per Minute (VPM) Change From Baseline	0.3; 0.62; -0.26; 0.52	—
SECONDARY Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline	0; 0.1; -0.16; 0.06	—
SECONDARY Narrative Verbs Per Minute (VPM)	0.25; 0.89; 0.35; 0.1	—
SECONDARY Procedural Verbs Per Minute (VPM) Change From Baseline	0.77; 1.1; -1.27; 0.84	—

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).

Eligibility Criteria

Inclusion Criteria

Aphasia as a result of a left hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04364854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.