Speech Therapy for Aphasia

(SpARc Trial)

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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the treatment Speech Entrainment Therapy for aphasia?

Research shows that Speech Entrainment Therapy, which involves mimicking an audiovisual speech model, can significantly improve speech fluency in individuals with non-fluent aphasia, particularly those with Broca's aphasia. Studies found that participants demonstrated increased speech output and fluency after using this therapy. ^{1 2 3 4 5}

Is speech entrainment therapy safe for humans?

The research does not provide specific safety data for speech entrainment therapy, but it is a non-invasive treatment that involves mimicking speech, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How does Speech Entrainment Therapy differ from other treatments for aphasia?

Speech Entrainment Therapy is unique because it involves mimicking an audiovisual speech model to improve speech fluency, which helps synchronize brain regions involved in language. This approach is particularly beneficial for individuals with non-fluent aphasia, as it compensates for damage in specific brain areas and enhances speech production more effectively than spontaneous speech practice. ^{1 2 3 4 7}

Research Team

Leonardo Bonilha, MD, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design. [2023]

2. United States 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. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Speech entrainment compensates for Broca's area damage. [2018]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Identifying mechanisms of change in a conversation therapy for aphasia using behaviour change theory and qualitative methods. [2019]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Pharmacological Treatments for Post-stroke Aphasia. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Neural structures supporting spontaneous and assisted (entrained) speech fluency. [2020]