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Speech Therapy for Aphasia (SpARc Trial)

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment (or no treatment)
Awards & highlights

SpARc Trial 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.Check my eligibility
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.See study design
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.

SpARc Trial 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.

SpARc Trial 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

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

SpARc 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
933 Previous Clinical Trials
7,394,535 Total Patients Enrolled
5 Trials studying Aphasia
347 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,216 Total Patients Enrolled
37 Trials studying Aphasia
2,709 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to adults aged eighteen or older?

"To meet the qualifications for this particular trial, applicants must be between 21 and 81 years old. Alternatively, there are 43 clinical studies available to those below 18 and 1060 trials open to seniors above 65."

Answered by AI

Does the FDA sanction Speech Entrainment Therapy for a duration of 6 weeks?

"The safety of Speech Entrainment Therapy over 6 weeks is estimated to be a 2 because this clinical trial is only in its second phase, indicating that though there has been some data collected on the therapy's security, none exists for efficacy."

Answered by AI

Who is able to sign up and participate in this medical trial?

"This experiment is recruiting 80 subjects affected by stroke, ranging in age from 21 to 81. The most important qualifications include the following: Aphasia due to a left hemisphere occlusion or bleeding (WAB-R Aphasia Quotient <93.8); confirmation of left hemisphere damage via CT/MRI scan and NIHSS; primary language spoken as English; pre-stroke mRS=2 or less, post-stroke mRS=4 or less; at least 6 months since stroke onset; nonfluency in communication (Comprehension score >4, Fluency score <6) and technological compatibility (as determined"

Answered by AI

Are there vacancies in this clinical trial for volunteers?

"That is correct. As per the information posted on clinicaltrials.gov, recruitment for this medical study has been ongoing since August 21st 2020 and was last updated on January 11th 2022. 80 patients from 3 different sites are needed to participate in the trial."

Answered by AI

Could you provide an estimation of the number of individuals taking part in this clinical trial?

"Affirmative. Data from clinicaltrials.gov verifies that this investigation, which was first posted on August 21st 2020, is actively seeking participants. A total of 80 patients need to be recruited across 3 separate sites."

Answered by AI

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
University of Utah
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Utah: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Speech Entrainment for Aphasia Recovery
Leonardo Bonilha 2020. "Speech Entrainment for Aphasia Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04364854.
All > Aphasia > Stroke
~16 spots leftby Apr 2025
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