NCT04364854CompletedPhase 2
Speech Entrainment for Aphasia Recovery
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 23 Apr 2020
- Start date
- 21 Aug 2020
- Primary completion date
- 8 May 2024
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Stroke
- NCT number
- NCT04364854
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 21 Aug 2020 to the primary completion date, 8 May 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of chronic neurological or psychiatric diseases (excluding migraines, depression, or post-stroke epilepsy). Self-reported history of learning disability.
- History of right-hemisphere strokes or brain stem/cerebellar strokes with persistent deficits (as evidenced by MRI/CT and NIHSS).
Other
- Severe dysarthria (determined via SLP clinical judgment from spontaneous speech tasks on the ASRS 3.0).
- Global aphasia.
- 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.
Who the study is looking for
- 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)
Age in the registry: 21 years to 81 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of South Carolina Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.