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Completed

NCT Number: NCT04364854

Speech Entrainment for Aphasia Recovery

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).

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Key information

Conditions

Aphasia Aphasia Non Fluent Aphasia, Broca Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

21 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SET (Speech Entrainment Therapy) 3 weeks

Behavioral

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 weeks

Behavioral

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 weeks

Behavioral

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

No Therapy 6 Weeks

Other

Participants will not be getting any SET for 6 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline

    Time frame: 3 months after treatment (or no treatment)

    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.

  2. Narrative Verbs Per Minute (VPM)

    Time frame: 3 months after treatment (or no treatment)

    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.

  3. Procedural Verbs Per Minute (VPM) Change From Baseline

    Time frame: 3 months after treatment (or no treatment)

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Acronym: SpARc

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 28, 2020
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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