Speech Entrainment for Aphasia Recovery

NCT04364854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-14

Study results available
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Summary

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).

Conditions

  • Aphasia
  • Aphasia Non Fluent
  • Stroke

Interventions

BEHAVIORAL

SET (Speech Entrainment Therapy) 3 weeks

3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

BEHAVIORAL

SET (Speech Entrainment Therapy) 4.5 weeks

4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

BEHAVIORAL

SET (Speech Entrainment Therapy) 6 weeks

6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program

OTHER

No Therapy 6 Weeks

Participants will not be getting any SET for 6 weeks

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Leonardo Bonilha, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-21
Primary Completion
2024-05-08
Completion
2025-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04364854 on ClinicalTrials.gov