Speech Therapy for Aphasia

(SpARc Trial)

No longer recruiting at 2 trial locations

Overseen By Stephanie Cute, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Disqualifiers: Chronic neurological, Psychiatric diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called Speech Entrainment Therapy (SET) for individuals with non-fluent aphasia, a condition where speaking becomes difficult after a stroke. The goal is to determine the optimal duration of SET for lasting speech improvements. Participants will join one of four groups: receiving SET for 3, 4.5, or 6 weeks, or receiving no treatment. The trial seeks individuals who have experienced a left-side stroke, speak English, and are at least 6 months post-stroke. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Speech Entrainment Therapy (SET) is a safe treatment for individuals with non-fluent aphasia, a condition affecting speech. Studies have found that participants who received SET improved their speech without serious side effects. In one study, 24 individuals with aphasia experienced increased brain activity when speaking. Previous patients demonstrated promising results, and no negative effects from the therapy itself have been reported. This suggests that SET is generally well-tolerated, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Speech Entrainment Therapy (SET) for aphasia because it offers a fresh approach to speech recovery. Unlike traditional speech therapies that often focus on repetitive language exercises, SET uses rhythmic and melodic cues to help patients synchronize their speech with external patterns, potentially enhancing fluency and speech timing. This method could be particularly effective in re-establishing speech pathways in the brain, offering a promising alternative to existing therapies. Additionally, the trial is exploring different durations of SET, which could provide insights into optimizing treatment length for better outcomes.

What evidence suggests that Speech Entrainment Therapy might be an effective treatment for non-fluent aphasia?

Research has shown that Speech Entrainment Therapy (SET), which participants in this trial may receive, helps people with non-fluent aphasia speak more smoothly. Studies have demonstrated significant improvement in speaking clearly and without mistakes among those using SET. Specifically, one study found that participants improved their speech by over 20% when speaking spontaneously. SET allows patients to copy a model they see and hear, aiding in more fluent speech. This method aligns with how the brain learns, making it effective for enhancing language skills. ^{1 6 7 8 9}

Who Is on the Research Team?

Leonardo Bonilha, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals aged 21-81 who have non-fluent aphasia due to a left hemisphere stroke, can speak English, and are at least 6 months post-stroke. They must not be pregnant, have severe dysarthria or global aphasia, uncorrectable vision/hearing issues, contraindications to MRI scans, or a history of right-hemisphere strokes or chronic neurological/psychiatric diseases.

Inclusion Criteria

I can walk and take care of myself after my stroke.

English is my primary language.

I have difficulty speaking but can understand well.

Exclusion Criteria

You have difficulty speaking and understanding language.

You have permanent hearing loss that cannot be fixed.

I have a vision problem that cannot be fixed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline language testing and an MRI

1 week

1 visit (in-person)

Treatment

Participants receive Speech Entrainment Therapy (SET) for 3, 4.5, or 6 weeks, or no treatment for control group

3-6 weeks

Varies based on group assignment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• No Therapy
• Speech Entrainment Therapy

Trial Overview

The study tests Speech Entrainment Therapy (SET) for improving speech in people with non-fluent aphasia after a stroke. Participants will be randomly assigned to receive SET for either 3 weeks, 4.5 weeks, or 6 weeks; there's also a control group that receives no therapy for comparison.

How Is the Trial Designed?

Group I: SET (Speech Entrainment Therapy) 6 weeks Experimental Treatment 1 Intervention

Group II: SET (Speech Entrainment Therapy) 4.5 weeks Experimental Treatment 1 Intervention

Group III: SET (Speech Entrainment Therapy) 3 weeks Experimental Treatment 1 Intervention

Group IV: No Therapy 6 weeks Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Speech entrainment (SE) helps individuals with non-fluent aphasia improve their speech fluency by normalizing functional connectivity between key language regions in the brain, making it more similar to that of neurotypical speakers.

In a study involving 24 individuals with aphasia and 20 controls, SE was found to enhance connectivity patterns during speech production, suggesting that SE may be an effective therapeutic approach for improving speech output in aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Connectivity and Speech Entrainment Speech Entrainment Improves Connectivity Between Anterior and Posterior Cortical Speech Areas in Non-fluent Aphasia. Johnson, L., Yourganov, G., Basilakos, A., et al.[2022]

Individuals with non-fluent aphasia who preserved certain brain structures, like the posterior middle temporal gyrus and specific fasciculi, showed better speech fluency when using speech entrainment compared to spontaneous speech.

The study suggests that damage to the dorsal stream of the brain, while preserving ventral stream structures, may enhance the effectiveness of speech entrainment as a rehabilitation technique for improving speech output in non-fluent aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural structures supporting spontaneous and assisted (entrained) speech fluency. Bonilha, L., Hillis, AE., Wilmskoetter, J., et al.[2020]

The SpARc trial is a multicenter phase II clinical trial involving 80 adults with chronic post-stroke non-fluent aphasia, aiming to evaluate the effectiveness of speech entrainment therapy (SET) over different durations (3, 4.5, or 6 weeks) compared to a control group.

Previous pilot studies indicated that SET can significantly improve speech production, as measured by verbs per minute (VPM), suggesting that this therapy may enhance fluent spontaneous speech in individuals with non-fluent aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design. Cassarly, C., Doyle, A., Ly, T., et al.[2023]

This study is a randomized controlled trial involving 126 patients with chronic aphasia, aiming to evaluate the effectiveness of intensive speech and language therapy (SLT) in improving everyday communication after stroke.

Participants will undergo at least 10 hours of therapy per week for three weeks, with outcomes measured using standardized tests to assess functional communication, providing robust evidence for the efficacy of SLT in chronic aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial. Baumgaertner, A., Grewe, T., Ziegler, W., et al.[2021]

The study identified seven mechanisms of change in conversational behavior for people with aphasia, highlighting how therapy enhances skills, motivation, and opportunities for effective communication.

The findings provide valuable insights into the processes that facilitate behavioral change during conversation therapy, distinguishing between motivating change and embedding new strategies, which can inform future clinical practices and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying mechanisms of change in a conversation therapy for aphasia using behaviour change theory and qualitative methods. Johnson, FM., Best, W., Beckley, FC., et al.[2019]

In a study of 44 chronic patients with left hemisphere stroke, those with Broca's aphasia showed a significant increase in speech fluency when using speech entrainment (SE) compared to spontaneous speech, indicating SE's effectiveness in enhancing speech production.

Voxel-wise lesion-symptom mapping revealed that damage to the inferior frontal gyrus is a predictor of positive response to SE, suggesting that specific patterns of cortical damage can help identify which patients may benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech entrainment compensates for Broca's area damage. Fridriksson, J., Basilakos, A., Hickok, G., et al.[2018]

Donepezil has been shown to significantly improve various aspects of language function in patients with post-stroke aphasia, including auditory comprehension, naming, repetition, and oral expression, based on a systematic review of 15 studies involving 578 participants.

Memantine also demonstrated efficacy in enhancing naming ability, spontaneous speech, and repetition, although it did not show significant improvement in auditory comprehension, indicating that different pharmacological treatments may have varying effects on language recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Pharmacological Treatments for Post-stroke Aphasia. Zhang, X., Shu, B., Zhang, D., et al.[2019]

Citations

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Speech Entrainment Treatment for People With Aphasia

These aims are addressed in a within-subject efficacy study, where 40 people with aphasia produce different stories with entrainment support.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0021992421000137

Speech timing changes accompany speech entrainment in ...

Prior speech entrainment studies, where individuals with non-fluent aphasia mimic an audio-visual model, suggest speech entrainment improves speech fluency, ...

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Effects of a new speech support application on intensive ...

Our results show that intensive speech therapy using this speech support app can improve language and attention functions even in the chronic stage of stroke.

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cdn.clinicaltrials.gov/large-docs/54/NCT04364854/Prot_001.pdf

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Speech entrainment therapy (SET) targets speech production in persons with non-fluent aphasia and has yielded promising results in phase I ...

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Speech Entrainment Treatment for People With Aphasia

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Speech Entrainment for Aphasia

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The first release of the Aphasia Recovery Cohort includes imaging data, demographics and behavioral measures from 230 chronic stroke survivors who experienced ...