Aphasia, Aphasia Non Fluent, Stroke
Conditions
Keywords
Aphasia, Speech Language Pathology, Therapy
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).
Interventions
BEHAVIORALSET (Speech Entrainment Therapy) 3 weeks
3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
BEHAVIORALSET (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
BEHAVIORALSET (Speech Entrainment Therapy) 6 weeks
6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
OTHERNo Therapy 6 Weeks
Participants will not be getting any SET for 6 weeks
Sponsors
Medical University of South Carolina
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 81 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Verbs Per Minute (VPM) Change From Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline | 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. |
| Narrative Verbs Per Minute (VPM) | 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. |
| Procedural Verbs Per Minute (VPM) Change From Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| 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 | 20 |
| No Therapy 6 Weeks No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Total | SET (Speech Entrainment Therapy) 3 Weeks | No Therapy 6 Weeks | SET (Speech Entrainment Therapy) 6 Weeks | SET (Speech Entrainment Therapy) 4.5 Weeks |
|---|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13.2 | 60.8 years STANDARD_DEVIATION 11.6 | 57.4 years STANDARD_DEVIATION 14.1 | 56.8 years STANDARD_DEVIATION 15 | 56.8 years STANDARD_DEVIATION 12.1 |
| ASRS | 19 score on a scale | 20 score on a scale | 17 score on a scale | 23 score on a scale | 18.5 score on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 18 Participants | 19 Participants | 19 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| LOFT Score | 45.5 score on a scale | 43.5 score on a scale | 49 score on a scale | 45 score on a scale | 44 score on a scale |
| Modified - PNT Score | 32.5 score on a scale | 18 score on a scale | 27 score on a scale | 25 score on a scale | 47 score on a scale |
| Modified - PRT Score | 102 score on a scale | 92.5 score on a scale | 97.5 score on a scale | 94.5 score on a scale | 133 score on a scale |
| Post-Stroke Fatigue Score | 2 score on a scale | 2 score on a scale | 4 score on a scale | 3 score on a scale | 2 score on a scale |
| Pyramids and Palm Trees Test Score | 45.5 score on a scale | 45.5 score on a scale | 47 score on a scale | 44 score on a scale | 45.5 score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 2 Participants | 4 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 66 Participants | 18 Participants | 16 Participants | 16 Participants | 16 Participants |
| RHHI-S Score | 0 score on a scale | 0 score on a scale | 0 score on a scale | 0 score on a scale | 0 score on a scale |
| SADQ Score | 10 score on a scale | 10.5 score on a scale | 10 score on a scale | 9 score on a scale | 11 score on a scale |
| Sex: Female, Male Female | 25 Participants | 7 Participants | 8 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 55 Participants | 13 Participants | 12 Participants | 17 Participants | 13 Participants |
| Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) | 3.44 score on a scale STANDARD_DEVIATION 0.72 | 3.61 score on a scale STANDARD_DEVIATION 0.67 | 3.43 score on a scale STANDARD_DEVIATION 0.83 | 3.12 score on a scale STANDARD_DEVIATION 0.67 | 3.59 score on a scale STANDARD_DEVIATION 0.63 |
| Stroke Onset Age | 53.5 years STANDARD_DEVIATION 13.8 | 55.1 years STANDARD_DEVIATION 13.4 | 55.1 years STANDARD_DEVIATION 15.4 | 52.6 years STANDARD_DEVIATION 13.3 | 51.6 years STANDARD_DEVIATION 14 |
| VPM - Average | 6.1 verbs per minute STANDARD_DEVIATION 6.4 | 7.3 verbs per minute STANDARD_DEVIATION 5.8 | 4.8 verbs per minute STANDARD_DEVIATION 3.6 | 3.8 verbs per minute STANDARD_DEVIATION 3.1 | 8.5 verbs per minute STANDARD_DEVIATION 9.7 |
| VPM - Narrative | 6.2 verbs per minute STANDARD_DEVIATION 7.8 | 8.7 verbs per minute STANDARD_DEVIATION 7.7 | 3.8 verbs per minute STANDARD_DEVIATION 3.7 | 3.1 verbs per minute STANDARD_DEVIATION 3.4 | 9.1 verbs per minute STANDARD_DEVIATION 11.5 |
| VPM - Procedural | 6.1 verbs per minute STANDARD_DEVIATION 6.3 | 5.8 verbs per minute STANDARD_DEVIATION 5.2 | 5.7 verbs per minute STANDARD_DEVIATION 5.3 | 4.7 verbs per minute STANDARD_DEVIATION 5.2 | 8.2 verbs per minute STANDARD_DEVIATION 8.6 |
| WAB-R | 47.8 score on a scale | 43.5 score on a scale | 53.9 score on a scale | 46.3 score on a scale | 49.4 score on a scale |
| WAIS III Matrix Reasoning Raw Score | 12 score on a scale | 8 score on a scale | 13 score on a scale | 11.5 score on a scale | 12.5 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 2 / 20 | 2 / 20 | 2 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3 months after treatment (or no treatment)
Population: Participants with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Average Verbs Per Minute (VPM) Change From Baseline | 0.3 verbs per minute |
| SET (Speech Entrainment Therapy) 4.5 weeks | Average Verbs Per Minute (VPM) Change From Baseline | 0.62 verbs per minute |
| SET (Speech Entrainment Therapy) 6 weeks | Average Verbs Per Minute (VPM) Change From Baseline | -0.26 verbs per minute |
| No Therapy 6 weeks | Average Verbs Per Minute (VPM) Change From Baseline | 0.52 verbs per minute |
95% CI: [-2.31, 1.87]
95% CI: [-2.94, 3.15]
95% CI: [-2.9, 1.33]
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.
Time frame: 3 months after treatment (or no treatment)
Population: Participants that have available data and did not withdraw consent prior to completing the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Narrative Verbs Per Minute (VPM) | 0.25 verbs per minute |
| SET (Speech Entrainment Therapy) 4.5 weeks | Narrative Verbs Per Minute (VPM) | 0.89 verbs per minute |
| SET (Speech Entrainment Therapy) 6 weeks | Narrative Verbs Per Minute (VPM) | 0.35 verbs per minute |
| No Therapy 6 weeks | Narrative Verbs Per Minute (VPM) | 0.1 verbs per minute |
95% CI: [-2.59, 2.9]
95% CI: [-2.23, 3.8]
95% CI: [-2.32, 2.82]
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.
Time frame: 3 months after treatment (or no treatment)
Population: Participants that have available data and did not withdraw consent prior to completing the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Procedural Verbs Per Minute (VPM) Change From Baseline | 0.77 verbs per minute |
| SET (Speech Entrainment Therapy) 4.5 weeks | Procedural Verbs Per Minute (VPM) Change From Baseline | 1.1 verbs per minute |
| SET (Speech Entrainment Therapy) 6 weeks | Procedural Verbs Per Minute (VPM) Change From Baseline | -1.27 verbs per minute |
| No Therapy 6 weeks | Procedural Verbs Per Minute (VPM) Change From Baseline | 0.84 verbs per minute |
95% CI: [-3.59, 3.45]
95% CI: [-4.27, 4.8]
95% CI: [-5.77, 1.56]
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.
Time frame: 3 months after treatment (or no treatment)
Population: Participants that have available data and did not withdraw consent prior to completing the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SET (Speech Entrainment Therapy) 3 weeks | Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline | 0 score on a scale |
| SET (Speech Entrainment Therapy) 4.5 weeks | Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline | 0.1 score on a scale |
| SET (Speech Entrainment Therapy) 6 weeks | Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline | -0.16 score on a scale |
| No Therapy 6 weeks | Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline | 0.06 score on a scale |
95% CI: [-0.26, 0.13]
95% CI: [-0.21, 0.28]
95% CI: [-0.42, -0.04]