Trial Outcomes & Findings for Speech Entrainment for Aphasia Recovery (NCT NCT04364854)
NCT ID: NCT04364854
Last Updated: 2025-11-14
Results Overview
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.
COMPLETED
PHASE2
80 participants
3 months after treatment (or no treatment)
2025-11-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
No Therapy 6 weeks
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
No Therapy 6 weeks
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Participants that had available data.
Baseline characteristics by cohort
| Measure |
SET (Speech Entrainment Therapy) 3 Weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 4.5 Weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 6 Weeks
n=20 Participants
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
|
No Therapy 6 Weeks
n=20 Participants
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.6 • n=20 Participants
|
56.8 years
STANDARD_DEVIATION 12.1 • n=20 Participants
|
56.8 years
STANDARD_DEVIATION 15 • n=20 Participants
|
57.4 years
STANDARD_DEVIATION 14.1 • n=20 Participants
|
58 years
STANDARD_DEVIATION 13.2 • n=80 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
25 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
55 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
76 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
66 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Stroke Onset Age
|
55.1 years
STANDARD_DEVIATION 13.4 • n=19 Participants • Participants that had available data.
|
51.6 years
STANDARD_DEVIATION 14 • n=20 Participants • Participants that had available data.
|
52.6 years
STANDARD_DEVIATION 13.3 • n=20 Participants • Participants that had available data.
|
55.1 years
STANDARD_DEVIATION 15.4 • n=20 Participants • Participants that had available data.
|
53.5 years
STANDARD_DEVIATION 13.8 • n=79 Participants • Participants that had available data.
|
|
VPM - Narrative
|
8.7 verbs per minute
STANDARD_DEVIATION 7.7 • n=20 Participants • Participants with available data.
|
9.1 verbs per minute
STANDARD_DEVIATION 11.5 • n=19 Participants • Participants with available data.
|
3.1 verbs per minute
STANDARD_DEVIATION 3.4 • n=20 Participants • Participants with available data.
|
3.8 verbs per minute
STANDARD_DEVIATION 3.7 • n=17 Participants • Participants with available data.
|
6.2 verbs per minute
STANDARD_DEVIATION 7.8 • n=76 Participants • Participants with available data.
|
|
VPM - Procedural
|
5.8 verbs per minute
STANDARD_DEVIATION 5.2 • n=20 Participants • Participants with available data.
|
8.2 verbs per minute
STANDARD_DEVIATION 8.6 • n=20 Participants • Participants with available data.
|
4.7 verbs per minute
STANDARD_DEVIATION 5.2 • n=19 Participants • Participants with available data.
|
5.7 verbs per minute
STANDARD_DEVIATION 5.3 • n=17 Participants • Participants with available data.
|
6.1 verbs per minute
STANDARD_DEVIATION 6.3 • n=76 Participants • Participants with available data.
|
|
VPM - Average
|
7.3 verbs per minute
STANDARD_DEVIATION 5.8 • n=20 Participants • Participants with available data.
|
8.5 verbs per minute
STANDARD_DEVIATION 9.7 • n=20 Participants • Participants with available data.
|
3.8 verbs per minute
STANDARD_DEVIATION 3.1 • n=20 Participants • Participants with available data.
|
4.8 verbs per minute
STANDARD_DEVIATION 3.6 • n=17 Participants • Participants with available data.
|
6.1 verbs per minute
STANDARD_DEVIATION 6.4 • n=77 Participants • Participants with available data.
|
|
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
|
3.61 score on a scale
STANDARD_DEVIATION 0.67 • n=20 Participants • Participants with available data.
|
3.59 score on a scale
STANDARD_DEVIATION 0.63 • n=20 Participants • Participants with available data.
|
3.12 score on a scale
STANDARD_DEVIATION 0.67 • n=20 Participants • Participants with available data.
|
3.43 score on a scale
STANDARD_DEVIATION 0.83 • n=18 Participants • Participants with available data.
|
3.44 score on a scale
STANDARD_DEVIATION 0.72 • n=78 Participants • Participants with available data.
|
|
WAB-R
|
43.5 score on a scale
n=20 Participants
|
49.4 score on a scale
n=20 Participants
|
46.3 score on a scale
n=20 Participants
|
53.9 score on a scale
n=20 Participants
|
47.8 score on a scale
n=80 Participants
|
|
ASRS
|
20 score on a scale
n=20 Participants • Participants with available data.
|
18.5 score on a scale
n=18 Participants • Participants with available data.
|
23 score on a scale
n=17 Participants • Participants with available data.
|
17 score on a scale
n=19 Participants • Participants with available data.
|
19 score on a scale
n=74 Participants • Participants with available data.
|
|
WAIS III Matrix Reasoning Raw Score
|
8 score on a scale
n=20 Participants • Participants with available data.
|
12.5 score on a scale
n=20 Participants • Participants with available data.
|
11.5 score on a scale
n=20 Participants • Participants with available data.
|
13 score on a scale
n=18 Participants • Participants with available data.
|
12 score on a scale
n=78 Participants • Participants with available data.
|
|
LOFT Score
|
43.5 score on a scale
n=20 Participants • Participants with available data.
|
44 score on a scale
n=20 Participants • Participants with available data.
|
45 score on a scale
n=20 Participants • Participants with available data.
|
49 score on a scale
n=18 Participants • Participants with available data.
|
45.5 score on a scale
n=78 Participants • Participants with available data.
|
|
Pyramids and Palm Trees Test Score
|
45.5 score on a scale
n=20 Participants • Participants with available data.
|
45.5 score on a scale
n=20 Participants • Participants with available data.
|
44 score on a scale
n=20 Participants • Participants with available data.
|
47 score on a scale
n=18 Participants • Participants with available data.
|
45.5 score on a scale
n=78 Participants • Participants with available data.
|
|
Post-Stroke Fatigue Score
|
2 score on a scale
n=20 Participants • Participants with available data.
|
2 score on a scale
n=20 Participants • Participants with available data.
|
3 score on a scale
n=20 Participants • Participants with available data.
|
4 score on a scale
n=18 Participants • Participants with available data.
|
2 score on a scale
n=78 Participants • Participants with available data.
|
|
RHHI-S Score
|
0 score on a scale
n=20 Participants
|
0 score on a scale
n=20 Participants
|
0 score on a scale
n=20 Participants
|
0 score on a scale
n=20 Participants
|
0 score on a scale
n=80 Participants
|
|
Modified - PNT Score
|
18 score on a scale
n=20 Participants • Participants with available data.
|
47 score on a scale
n=20 Participants • Participants with available data.
|
25 score on a scale
n=20 Participants • Participants with available data.
|
27 score on a scale
n=18 Participants • Participants with available data.
|
32.5 score on a scale
n=78 Participants • Participants with available data.
|
|
Modified - PRT Score
|
92.5 score on a scale
n=20 Participants • Participants with available data.
|
133 score on a scale
n=20 Participants • Participants with available data.
|
94.5 score on a scale
n=20 Participants • Participants with available data.
|
97.5 score on a scale
n=18 Participants • Participants with available data.
|
102 score on a scale
n=78 Participants • Participants with available data.
|
|
SADQ Score
|
10.5 score on a scale
n=20 Participants • Participants with available data.
|
11 score on a scale
n=20 Participants • Participants with available data.
|
9 score on a scale
n=20 Participants • Participants with available data.
|
10 score on a scale
n=18 Participants • Participants with available data.
|
10 score on a scale
n=78 Participants • Participants with available data.
|
PRIMARY outcome
Timeframe: 3 months after treatment (or no treatment)Population: Participants with available data.
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.
Outcome measures
| Measure |
SET (Speech Entrainment Therapy) 3 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 4.5 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 6 weeks
n=20 Participants
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
|
No Therapy 6 weeks
n=18 Participants
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Average Verbs Per Minute (VPM) Change From Baseline
|
0.3 verbs per minute
Interval -1.25 to 1.86
|
0.62 verbs per minute
Interval -2.15 to 3.39
|
-0.26 verbs per minute
Interval -1.96 to 1.43
|
0.52 verbs per minute
Interval -0.85 to 1.89
|
SECONDARY outcome
Timeframe: 3 months after treatment (or no treatment)Population: Participants that have available data and did not withdraw consent prior to completing the study.
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.
Outcome measures
| Measure |
SET (Speech Entrainment Therapy) 3 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 4.5 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 6 weeks
n=20 Participants
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
|
No Therapy 6 weeks
n=18 Participants
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline
|
0 score on a scale
Interval -0.15 to 0.15
|
0.1 score on a scale
Interval -0.11 to 0.3
|
-0.16 score on a scale
Interval -0.3 to -0.02
|
0.06 score on a scale
Interval -0.06 to 0.19
|
SECONDARY outcome
Timeframe: 3 months after treatment (or no treatment)Population: Participants that have available data and did not withdraw consent prior to completing the study.
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.
Outcome measures
| Measure |
SET (Speech Entrainment Therapy) 3 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 4.5 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 6 weeks
n=20 Participants
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
|
No Therapy 6 weeks
n=18 Participants
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Narrative Verbs Per Minute (VPM)
|
0.25 verbs per minute
Interval -1.92 to 2.43
|
0.89 verbs per minute
Interval -1.71 to 3.49
|
0.35 verbs per minute
Interval -1.74 to 2.44
|
0.1 verbs per minute
Interval -1.56 to 1.75
|
SECONDARY outcome
Timeframe: 3 months after treatment (or no treatment)Population: Participants that have available data and did not withdraw consent prior to completing the study.
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.
Outcome measures
| Measure |
SET (Speech Entrainment Therapy) 3 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 4.5 weeks
n=20 Participants
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
|
SET (Speech Entrainment Therapy) 6 weeks
n=20 Participants
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
|
No Therapy 6 weeks
n=18 Participants
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Procedural Verbs Per Minute (VPM) Change From Baseline
|
0.77 verbs per minute
Interval -1.78 to 3.31
|
1.1 verbs per minute
Interval -2.58 to 4.79
|
-1.27 verbs per minute
Interval -4.2 to 1.67
|
0.84 verbs per minute
Interval -1.65 to 3.33
|
Adverse Events
SET (Speech Entrainment Therapy) 3 weeks
SET (Speech Entrainment Therapy) 4.5 weeks
SET (Speech Entrainment Therapy) 6 weeks
No Therapy 6 weeks
Serious adverse events
| Measure |
SET (Speech Entrainment Therapy) 3 weeks
n=20 participants at risk
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
|
SET (Speech Entrainment Therapy) 4.5 weeks
n=20 participants at risk
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
|
SET (Speech Entrainment Therapy) 6 weeks
n=20 participants at risk
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
|
No Therapy 6 weeks
n=20 participants at risk
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
|
General disorders
Adverse drug reaction
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
|
Nervous system disorders
Post stroke seizure
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
Other adverse events
| Measure |
SET (Speech Entrainment Therapy) 3 weeks
n=20 participants at risk
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
|
SET (Speech Entrainment Therapy) 4.5 weeks
n=20 participants at risk
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
|
SET (Speech Entrainment Therapy) 6 weeks
n=20 participants at risk
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
|
No Therapy 6 weeks
n=20 participants at risk
No Therapy 6 Weeks: Participants will not be getting any SET for 6 weeks
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
5.0%
1/20 • Number of events 1 • 6 months after treatment (or no treatment).
|
0.00%
0/20 • 6 months after treatment (or no treatment).
|
Additional Information
Principal Investigator
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place