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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

3 months after treatment (or no treatment)

Results posted on

2025-11-14

Participant Flow

Participant milestones

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

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

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

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

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

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

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

Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths

SET (Speech Entrainment Therapy) 4.5 weeks

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

SET (Speech Entrainment Therapy) 6 weeks

Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths

No Therapy 6 weeks

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 843-876-8311

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place