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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC017521-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Experimental |
| |
| SET (Speech Entrainment Therapy) 4.5 weeks | Experimental |
| |
| SET (Speech Entrainment Therapy) 6 weeks | Experimental |
| |
| No Therapy 6 weeks | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after treatment (or no treatment) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Bonilha, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States | ||
| University of South Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | SET (Speech Entrainment Therapy) 3 weeks | SET (Speech Entrainment Therapy) 3 weeks: 3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| FG001 | SET (Speech Entrainment Therapy) 4.5 weeks | SET (Speech Entrainment Therapy) 4.5 weeks: 4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| FG002 | SET (Speech Entrainment Therapy) 6 weeks | SET (Speech Entrainment Therapy) 6 weeks: 6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| FG003 | No Therapy 6 weeks | No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SET (Speech Entrainment Therapy) 3 Weeks | SET (Speech Entrainment Therapy) 3 weeks: 3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| BG001 | SET (Speech Entrainment Therapy) 4.5 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of enrollment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with available data. | Posted | Least Squares Mean | 95% Confidence Interval | verbs per minute | 3 months after treatment (or no treatment) |
|
6 months after treatment (or no treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SET (Speech Entrainment Therapy) 3 weeks | SET (Speech Entrainment Therapy) 3 weeks: 3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (23) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (23) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Medical University of South Carolina | 843-876-8311 | bonilha@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2024 | Mar 11, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2024 | Mar 11, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2021 | Mar 11, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D001039 | Aphasia, Broca |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| C513473 | SET protein, human |
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| 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 |
|
| 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. | 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. | 3 months after treatment (or no treatment) |
| Columbia |
| South Carolina |
| 29208 |
| United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Death |
|
| Lost to Follow-up |
|
SET (Speech Entrainment Therapy) 4.5 weeks: 4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| BG002 | SET (Speech Entrainment Therapy) 6 Weeks | SET (Speech Entrainment Therapy) 6 weeks: 6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| BG003 | No Therapy 6 Weeks | No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Stroke Onset Age | Age of the participant at the time of stroke that resulted in chronic aphasia. | Participants that had available data. | Mean | Standard Deviation | years |
|
| VPM - Narrative | Verbs per minute (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. | Participants with available data. | Mean | Standard Deviation | verbs per minute |
|
| VPM - Procedural | Verbs per minute (VPM) will be assessed through procedural storytelling - with four different stories. The procedural stories 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. | Participants with available data. | Mean | Standard Deviation | verbs per minute |
|
| VPM - Average | Verbs per minute (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. | Participants with available data. | Mean | Standard Deviation | verbs per minute |
|
| Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) | 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. | Participants with available data. | Mean | Standard Deviation | score on a scale |
|
| WAB-R | Western Aphasia Battery-Revised (WAB-R) is a common clinical aphasia assessment used to determine the presence of non-fluent aphasia. The final score (known as the aphasia quotient) takes a value between 0 to 100 with lower scores indicating more severe aphasia and higher scores indicating less severe aphasia. | Median | Inter-Quartile Range | score on a scale |
|
| ASRS | Apraxia of Speech Rating Scale (ASRS) assesses the apraxia of speech of participants. The final score takes a value between 0 and 52 with a lower score indicating less severe apraxia and higher scores indicating more severe apraxia. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| WAIS III Matrix Reasoning Raw Score | Wechsler Adult Intelligence Scale (WAIS) III is an overall assessment of intellectual abilities. Only the matrix reasoning subtest score will be reported here which assesses nonverbal reasoning abilities. This score takes a value between 0 and 26 with a higher score indicating better abilities. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| LOFT Score | Lexical Orthography Familiarity Test (LOFT) is a type of assessment used to measure how familiar someone is with the written forms of words. The score takes a value between 0 and 50 with a higher score indicating more familiarity with words. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| Pyramids and Palm Trees Test Score | The Pyramids and Palm Trees Test assesses a participant's ability to access semantic memory by identifying conceptual relationships between words and pictures. The score takes a value between 0 and 52 with a higher score indicating better semantic memory abilities. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| Post-Stroke Fatigue Score | The Vertical Numerical Rating Scale-Face Rating Scale is a measure of fatigue severity in a stroke patient. The score takes a value between 0 and 10 with 0 representing no fatigue and 10 representing extreme fatigue. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| RHHI-S Score | The Revised Hearing Handicap Inventory Screening (RHHIS) assesses the level of a participant's self-reported hearing difficulty. The score ranges from 0 to 40 with a higher score indicating more difficult hearing ability. | Median | Inter-Quartile Range | score on a scale |
|
| Modified - PNT Score | The modified Philadelphia Naming Test (PNT) is a picture naming test that assesses word retrieval. The final score ranges from 0 to 175 with higher scores indicating better naming ability. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| Modified - PRT Score | The modified Philadelphia Repetition Test (PRT) assesses a participant's ability to orally repeat a name he/she heard. The score takes a value between 0 and 175 with a higher score indicating better repetition ability. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| SADQ Score | The Stroke Aphasia Depression Questionnaire (SADQ) is a measure of depression for people who have aphasia due to stroke. The final score ranges between 0 and 30 with higher scores indicating more severe depression. | Participants with available data. | Median | Inter-Quartile Range | score on a scale |
|
| OG001 | SET (Speech Entrainment Therapy) 4.5 weeks | SET (Speech Entrainment Therapy) 4.5 weeks: 4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| OG002 | SET (Speech Entrainment Therapy) 6 weeks | SET (Speech Entrainment Therapy) 6 weeks: 6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program |
| OG003 | No Therapy 6 weeks | No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks |
|
|
|
| Secondary | 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. | Participants that have available data and did not withdraw consent prior to completing the study. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 3 months after treatment (or no treatment) |
|
|
|
|
| Secondary | 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. | Participants that have available data and did not withdraw consent prior to completing the study. | Posted | Least Squares Mean | 95% Confidence Interval | verbs per minute | 3 months after treatment (or no treatment) |
|
|
|
|
| Secondary | 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. | Participants that have available data and did not withdraw consent prior to completing the study. | Posted | Least Squares Mean | 95% Confidence Interval | verbs per minute | 3 months after treatment (or no treatment) |
|
|
|
|
| 1 |
| 20 |
| 2 |
| 20 |
| 0 |
| 20 |
| EG001 | SET (Speech Entrainment Therapy) 4.5 weeks | SET (Speech Entrainment Therapy) 4.5 weeks: 4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program | 0 | 20 | 2 | 20 | 0 | 20 |
| EG002 | SET (Speech Entrainment Therapy) 6 weeks | SET (Speech Entrainment Therapy) 6 weeks: 6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program | 0 | 20 | 2 | 20 | 1 | 20 |
| EG003 | No Therapy 6 weeks | No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks | 0 | 20 | 0 | 20 | 0 | 20 |
| Adverse drug reaction | General disorders | MedDRA (23) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (23) | Non-systematic Assessment |
|
| Post stroke seizure | Nervous system disorders | MedDRA (23) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (23) | Non-systematic Assessment |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Net) |
| 0.03 |
| 2-Sided |
| 95 |
| -0.21 |
| 0.28 |
Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age. |
| Other |
This trial was not designed for hypothesis testing. No p-values will be reported. |
| Mean Difference (Net) | -0.23 | 2-Sided | 95 | -0.42 | -0.04 | Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age. | Other | This trial was not designed for hypothesis testing. No p-values will be reported. |
| Mean Difference (Net) |
| 0.79 |
| 2-Sided |
| 95 |
| -2.23 |
| 3.8 |
Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM-Narrative, and age. |
| Other |
This trial was not designed for hypothesis testing. No p-values will be reported. |
| Mean Difference (Net) | 0.25 | 2-Sided | 95 | -2.32 | 2.82 | Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age. | Other | This trial was not designed for hypothesis testing. No p-values will be reported. |
| Mean Difference (Net) |
| 0.27 |
| 2-Sided |
| 95 |
| -4.27 |
| 4.8 |
Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age. |
| Other |
This trial was not designed for hypothesis testing. No p-values will be reported. |
| Mean Difference (Net) | -2.11 | 2-Sided | 95 | -5.77 | 1.56 | Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age. | Other | This trial was not designed for hypothesis testing. No p-values will be reported. |