Speech Entrainment for Aphasia Recovery (NCT04364854) | Clinical Trial Compass
CompletedPhase 2
Speech Entrainment for Aphasia Recovery
United States80 participantsStarted 2020-08-21
Plain-language 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).
Who can participate
Age range
21 Years – 81 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Verbs Per Minute (VPM) Change From Baseline
Timeframe: 3 months after treatment (or no treatment)