AphasiaPhase 2SpARcNCT04364854
Speech Entrainment for Aphasia Recovery
A Phase 2 study testing SET (Speech Entrainment Therapy) 3 weeks, SET (Speech Entrainment Therapy) 4.5 weeks and SET (Speech Entrainment Therapy) 6 weeks in people with Aphasia and Aphasia Non Fluent, run by Medical University of South Carolina at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 81 years
- Conditions the study is for
- Aphasia, Aphasia Non Fluent, Stroke
- What is being tested?
- SET (Speech Entrainment Therapy) 3 weeks, SET (Speech Entrainment Therapy) 4.5 weeks and SET (Speech Entrainment Therapy) 6 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2020to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29401
University of South Carolina
Columbia, South Carolina, 29208
University of Utah
Salt Lake City, Utah, 84112
About this study
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).
- Conditions
- Aphasia, Aphasia Non Fluent, Stroke
- Being tested
- SET (Speech Entrainment Therapy) 3 weeks, SET (Speech Entrainment Therapy) 4.5 weeks, SET (Speech Entrainment Therapy) 6 weeks, No Therapy 6 Weeks
- Keywords
- Aphasia, Speech Language Pathology, Therapy
- Medical subject headings
- Aphasia, Aphasia, Broca, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SET (Speech Entrainment Therapy) 3 weeksBehavioural
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 weeksBehavioural
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 weeksBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Experimental | Not described Receives: Behavioral: SET (Speech Entrainment Therapy) 3 weeks |
| SET (Speech Entrainment Therapy) 4.5 weeks | Experimental | Not described Receives: Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks |
| SET (Speech Entrainment Therapy) 6 weeks | Experimental | Not described Receives: Behavioral: SET (Speech Entrainment Therapy) 6 weeks |
| No Therapy 6 weeks | Other | Not described Receives: Other: No Therapy 6 Weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Verbs Per Minute (VPM) Change From Baseline
VPM will be assessed through procedural storytelling and narrative storytelling 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.
VPM is averaged between the procedural storytelling and narrative storytelling tasks.
Measured: 3 months after treatment (or no treatment)
Secondary outcomes (3)
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) is a health-related quality of life measure that evaluates a participant's physical, psychosocial, and communication functioning. The final score is a decimal number between 0 and 5 with 5 indicating the best quality of life.
Measured: 3 months after treatment (or no treatment)
Narrative Verbs Per Minute (VPM)
VPM will be assessed through narrative storytelling tasks - with four different stories. The narrative stories will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks.
Measured: 3 months after treatment (or no treatment)
Procedural Verbs Per Minute (VPM) Change From Baseline
Verbs per minute (VPM) will be assessed through procedural storytelling - with four different stories. 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.
Measured: 3 months after treatment (or no treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start21 Aug 2020
- Primary completion8 May 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Leonardo Bonilha, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364854
- Sponsor's protocol ID
- 00091924
- Other IDs
- U01DC017521-01A1
- Acronym
- SpARc
- Status last verified
- Oct 2025
- First submitted
- 23 Apr 2020
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Entrainment for Aphasia Recovery
- ClinicalTrials.gov ID
- NCT04364854
- Acronym / sponsor ID
- SpARc / 00091924
- Conditions
- Aphasia, Aphasia Non Fluent, Stroke
- Keywords
- Aphasia, Speech Language Pathology, Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 1 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Experimental | Behavioral: SET (Speech Entrainment Therapy) 3 weeks |
| SET (Speech Entrainment Therapy) 4.5 weeks | Experimental | Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks |
| SET (Speech Entrainment Therapy) 6 weeks | Experimental | Behavioral: SET (Speech Entrainment Therapy) 6 weeks |
| No Therapy 6 weeks | Other | Other: No Therapy 6 Weeks |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program | Behavioural | SET (Speech Entrainment Therapy) 3 weeks |
| SET (Speech Entrainment Therapy) 4.5 weeks4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program | Behavioural | SET (Speech Entrainment Therapy) 4.5 weeks |
| SET (Speech Entrainment Therapy) 6 weeks6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program | Behavioural | SET (Speech Entrainment Therapy) 6 weeks |
| No Therapy 6 WeeksParticipants will not be getting any SET for 6 weeks | Other | No Therapy 6 weeks |
Primary outcome
Average Verbs Per Minute (VPM) Change From Baseline
Time frame: 3 months after treatment (or no treatment)
VPM will be assessed through procedural storytelling and narrative storytelling 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. VPM is averaged between the procedural storytelling and narrative storytelling tasks.
3 secondary outcomes
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline
Time frame: 3 months after treatment (or no treatment)
Narrative Verbs Per Minute (VPM)
Time frame: 3 months after treatment (or no treatment)
Procedural Verbs Per Minute (VPM) Change From Baseline
Time frame: 3 months after treatment (or no treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Bonilha, MD, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SET (Speech Entrainment Therapy) 3 weeks, SET (Speech Entrainment Therapy) 4.5 weeks and SET (Speech Entrainment Therapy) 6 weeks in people with Aphasia and Aphasia Non Fluent, run by Medical University of South Carolina at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Verbs Per Minute (VPM) Change From Baseline (time frame: 3 months after treatment (or no treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.