Speech Entrainment for Aphasia Recovery
SpARc
2 other identifiers
interventional
80
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2020
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
August 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2024
CompletedResults Posted
Study results publicly available
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedNovember 14, 2025
October 1, 2025
3.7 years
April 23, 2020
March 11, 2025
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months after treatment (or no treatment)
Secondary Outcomes (3)
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline
3 months after treatment (or no treatment)
Narrative Verbs Per Minute (VPM)
3 months after treatment (or no treatment)
Procedural Verbs Per Minute (VPM) Change From Baseline
3 months after treatment (or no treatment)
Study Arms (4)
SET (Speech Entrainment Therapy) 3 weeks
EXPERIMENTALSET (Speech Entrainment Therapy) 4.5 weeks
EXPERIMENTALSET (Speech Entrainment Therapy) 6 weeks
EXPERIMENTALNo Therapy 6 weeks
OTHERInterventions
3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
Eligibility Criteria
You may qualify if:
- 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.
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Medical University of South Carolina
Charleston, South Carolina, 29401, United States
University of South Carolina
Columbia, South Carolina, 29208, United States
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Leonardo Bonilha, MD, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2020
First Posted
April 28, 2020
Study Start
August 21, 2020
Primary Completion
May 8, 2024
Study Completion
August 31, 2025
Last Updated
November 14, 2025
Results First Posted
April 1, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share