CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
SET (Speech Entrainment Therapy) 3 weeks +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04364854
NCT04364854Phase 2Completed
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Speech Entrainment for Aphasia Recovery

Medical University of South Carolina·interventional·Posted Apr 28, 2020·Updated Nov 14, 2025

In Brief

A Phase 2 clinical trial evaluating SET (Speech Entrainment Therapy) 3 weeks, SET (Speech Entrainment Therapy) 4.5 weeks, and 2 other interventions for Aphasia and 2 related conditions. Completed, enrolled 80 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAphasia, Aphasia Non Fluent, Stroke
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartAug 21, 2020
Primary CompletionMay 8, 2024
Study CompletionAug 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.2 years ago

Interventions

SET (Speech Entrainment Therapy) 3 weeksbehavioral

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 weeksbehavioral

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 weeksbehavioral

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

No Therapy 6 Weeksother

Participants will not be getting any SET for 6 weeks