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Speech Therapy for Aphasia (SpARc Trial)

Phase 2
Waitlist Available
Led By Leonardo Bonilha, MD, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-stroke mRS= 4 or less
Participants must have spoken English as their primary language
Must not have
Uncorrectable vision
Women who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment (or no treatment)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a speech entrainment therapy can help people with aphasia produce more speech.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves speech therapy rather than medication or surgery, traditional side effects are not expected. However, participants may experience fatigue or frustration during the intensive language tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk and take care of myself after my stroke.
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English is my primary language.
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I have difficulty speaking but can understand well.
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I have difficulty speaking due to a stroke in the left side of my brain.
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Before my stroke, I had slight or no disability.
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I am between 21 and 81 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a vision problem that cannot be fixed.
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I am currently pregnant.
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I have had a stroke in the right side of my brain or in the brain stem/cerebellum with lasting effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after treatment (or no treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after treatment (or no treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Verbs Per Minute (VPM) in Speech Sample
Secondary study objectives
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: SET (Speech Entrainment Therapy) 6 weeksExperimental Treatment1 Intervention
Group II: SET (Speech Entrainment Therapy) 4.5 weeksExperimental Treatment1 Intervention
Group III: SET (Speech Entrainment Therapy) 3 weeksExperimental Treatment1 Intervention
Group IV: No Therapy 6 weeksExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
977 Previous Clinical Trials
7,400,907 Total Patients Enrolled
5 Trials studying Aphasia
347 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
354 Previous Clinical Trials
181,655 Total Patients Enrolled
39 Trials studying Aphasia
2,744 Patients Enrolled for Aphasia
Leonardo Bonilha, MD, PhDPrincipal Investigator - Emory University
Medical University of South Carolina

Media Library

Speech Entrainment Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04364854 — Phase 2
Aphasia Research Study Groups: SET (Speech Entrainment Therapy) 3 weeks, SET (Speech Entrainment Therapy) 6 weeks, No Therapy 6 weeks, SET (Speech Entrainment Therapy) 4.5 weeks
Aphasia Clinical Trial 2023: Speech Entrainment Therapy Highlights & Side Effects. Trial Name: NCT04364854 — Phase 2
Speech Entrainment Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364854 — Phase 2
~15 spots leftby Dec 2025
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