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Clinical Trials/NCT04364854
NCT04364854
Completed
Phase 2

Speech Entrainment for Aphasia Recovery

Medical University of South Carolina3 sites in 1 country80 target enrollmentAugust 21, 2020

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Aphasia
Sponsor
Medical University of South Carolina
Enrollment
80
Locations
3
Primary Endpoint
Average Verbs Per Minute (VPM) Change From Baseline
Status
Completed
Last Updated
5 months ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
August 21, 2020
End Date
August 31, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Average Verbs Per Minute (VPM) Change From Baseline

Time Frame: 3 months after treatment (or no treatment)

VPM will be assessed through procedural storytelling and narrative storytelling tasks - with four items in each category. The procedural storytelling items are: 1) how to make a peanut butter and jelly sandwich, 2) how to make scrambled eggs, 3) how to brew coffee, and 4) how to wash dishes. The narrative items will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks. VPM is averaged between the procedural storytelling and narrative storytelling tasks.

Secondary Outcomes

  • Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline(3 months after treatment (or no treatment))
  • Narrative Verbs Per Minute (VPM)(3 months after treatment (or no treatment))
  • Procedural Verbs Per Minute (VPM) Change From Baseline(3 months after treatment (or no treatment))

Study Sites (3)

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