# Speech Entrainment for Aphasia Recovery (SpARc)

> **NIH NIH U01** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2021 · $846,150

## Abstract

Abstract
 In spite of recent advances in the treatment of acute stroke, 20% of chronic stroke survivors suffer from
long-lasting language impairments (aphasia). Non-fluent aphasia is one of the most common forms of aphasia,
and it is directly associated with social isolation, decreased participation in rehabilitation therapies, and low
quality of life. The reestablishment of fluent speech is one of the most challenging aspects during the treatment
of subjects with chronic non-fluent aphasia. As a novel alternative to this problem, our group has optimized a
new and promising treatment approach entitled speech entrainment therapy (SET), where the subject's speech
is pulled along (guided by) an audio-visual model presented on a laptop computer. In a preliminary and proof of
concept study, we observed that subjects with non-fluent aphasia could overcome the barrier towards fluency
and produce more fluent speech with SET. They had greater than 20% improvement in verbs per minute
(VPM) during spontaneous speech at three months after therapy. These are very encouraging findings
because they represent sustained post-treatment gains in producing verbs during discourse, which is a valid
ecological measure, and a better predictor of language abilities compared with producing nouns or naming
objects. Motivated by these findings, we propose a prospective controlled randomized assessor blinded phase
II clinical trial entitled Speech entrainment for Aphasia Recovery (SpARc) to better assess the linguistic
improvements associated with SET, and to determine the optimal dose of SET. This trial will be a multisite (5
sites) project that will enroll 150 chronically stable stroke survivors with non-fluent aphasia, and the primary
outcome will be VPM at 3 months post-therapy. We will use a Seamless Two-Stage Dose Selection design,
which will include a Stage 1 to choose the best SET dose, and a Stage 2 to assess the full effects of SET. In
Stage 1, the patients will be randomized to 3 different doses of SET: 3 or 4.5 or 6 weeks of 1 hour daily SET,
or a control (no treatment) condition (20 patients in each one of the 4 groups). Based on a pre-defined rule, we
will select the dose that demonstrated adequate tolerability and was associated the highest group average
VPM at 3 months post treatment. In Stage 2, we will enroll 70 additional patients and randomly assign them 1:1
to either the selected SET duration or the control group. The final analysis will test whether the change from
baseline in VPM for the selected SET duration group is better than the control group using patients enrolled in
Stages 1 and 2. SET will be considered worthy of further study if it leads to an improvement in 20% or more in
VPM at 3 months after therapy compared with the no treatment control condition. This study will provide a
better understanding of the therapeutic benefits of SET, determine its best dose, and decide whether its effects
would justify future studies of this new and promising ...

## Key facts

- **NIH application ID:** 10241330
- **Project number:** 5U01DC017521-03
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** Leonardo F Bonilha
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $846,150
- **Award type:** 5
- **Project period:** 2019-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241330

## Citation

> US National Institutes of Health, RePORTER application 10241330, Speech Entrainment for Aphasia Recovery (SpARc) (5U01DC017521-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10241330. Licensed CC0.

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