NCT04364854: SpARc

Speech Entrainment for Aphasia Recovery

Completed Phase 2 Results posted Last updated 14 November 2025

What this trial tests

Phase 2 trial testing SET (Speech Entrainment Therapy) 3 weeks in Aphasia in 80 participants. Completed in 31 August 2025.

Timeline

21 August 2020

Primary endpoint
8 May 2024

31 August 2025

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	21 August 2020
Primary completion	8 May 2024
Estimated completion	31 August 2025
Sites	3 locations across United States

Drugs / interventions tested

• SET (Speech Entrainment Therapy) 3 weeks
• SET (Speech Entrainment Therapy) 4.5 weeks
• SET (Speech Entrainment Therapy) 6 weeks
• No Therapy 6 Weeks

Conditions studied

• Aphasia — all drugs for Aphasia →
• Aphasia Non Fluent — all drugs for Aphasia Non Fluent →
• Stroke — all drugs for Stroke →

Sponsor

Medical University of South Carolina

Who can join

Adults 21 to 81, any sex, with Aphasia or Aphasia Non Fluent. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Verbs Per Minute (VPM) Change From Baseline Primary · 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.

Group	Value	95% CI
SET (Speech Entrainment Therapy) 3 weeks	0.3	-1.25 – 1.86
SET (Speech Entrainment Therapy) 4.5 weeks	0.62	-2.15 – 3.39
SET (Speech Entrainment Therapy) 6 weeks	-0.26	-1.96 – 1.43
No Therapy 6 weeks	0.52	-0.85 – 1.89

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

Group	Value	95% CI
SET (Speech Entrainment Therapy) 3 weeks	0	-0.15 – 0.15
SET (Speech Entrainment Therapy) 4.5 weeks	0.1	-0.11 – 0.3
SET (Speech Entrainment Therapy) 6 weeks	-0.16	-0.3 – -0.02
No Therapy 6 weeks	0.06	-0.06 – 0.19

Narrative Verbs Per Minute (VPM) Secondary · 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.

Group	Value	95% CI
SET (Speech Entrainment Therapy) 3 weeks	0.25	-1.92 – 2.43
SET (Speech Entrainment Therapy) 4.5 weeks	0.89	-1.71 – 3.49
SET (Speech Entrainment Therapy) 6 weeks	0.35	-1.74 – 2.44
No Therapy 6 weeks	0.1	-1.56 – 1.75

Procedural Verbs Per Minute (VPM) Change From Baseline Secondary · 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.

Group	Value	95% CI
SET (Speech Entrainment Therapy) 3 weeks	0.77	-1.78 – 3.31
SET (Speech Entrainment Therapy) 4.5 weeks	1.1	-2.58 – 4.79
SET (Speech Entrainment Therapy) 6 weeks	-1.27	-4.2 – 1.67
No Therapy 6 weeks	0.84	-1.65 – 3.33

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months after treatment (or no treatment).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SET (Speech Entrainment Therapy) 3 weeks

Serious: 2/20 (10%)

Deaths: 1/20

SET (Speech Entrainment Therapy) 4.5 weeks

Serious: 2/20 (10%)

Deaths: 0/20

SET (Speech Entrainment Therapy) 6 weeks

Serious: 2/20 (10%)

Deaths: 0/20

No Therapy 6 weeks

Serious: 0/20 (0%)

Deaths: 0/20

Serious adverse events (6 terms)

Reaction	System	SET (Speech Entrainment Th…	SET (Speech Entrainment Th…	SET (Speech Entrainment Th…	No Therapy 6 weeks
Vertigo	Ear and labyrinth disorders	—	—	—	—
Adverse drug reaction	General disorders	—	—	—	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—
Post stroke seizure	Nervous system disorders	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	SET (Speech Entrainment Th…	SET (Speech Entrainment Th…	SET (Speech Entrainment Th…	No Therapy 6 weeks
Anxiety	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: Vertigo, Adverse drug reaction, Lung neoplasm malignant, Cerebrovascular accident, Post stroke seizure, Seizure.

Data from ClinicalTrials.gov NCT04364854 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-pharmacological interventions for improving language and communication in people with primary progressive aphasia.
   Roheger M, Riemann S, Brauer A, McGowan E, et al · · 2024 · cited 13× · PMID 38808659 · DOI 10.1002/14651858.cd015067.pub2