Speech Entrainment for Aphasia Recovery (SpARc)

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia; Aphasia Non Fluent
• Intervention / Treatment: Behavioral: SET (Speech Entrainment Therapy) 3 weeks; Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks; Behavioral: SET (Speech Entrainment Therapy) 6 weeks; Other: No Therapy 6 Weeks

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kelly Krajeck, MHA; Phone Number: (843) 792-0189; Email: krajeck@musc.edu
• Study Contact Backup: Name: Stephanie Cute, CCC-SLP; Phone Number: (843) 792-3678; Email: cute@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Janina Wilmskoetter, PhD
      • Contact: Stephanie Cute, CCC-SLP; Phone Number: 843-792-3678; Email: cute@musc.edu
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Mary Aitchison, PhD; Phone Number: 803-777-5905; Email: mjaitchi@mailbox.sc.edu
      • Principal Investigator: Julius Fridriksson, PhD
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Julie Wambaugh, PhD; Phone Number: 801-585-6164; Email: julie.wambaugh@health.utah.edu
      • Principal Investigator: Robert Kraemer, PhD
      • Principal Investigator: Julie Wambaugh, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Aphasia as a result of a left hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient <93.8).
• Presence of left hemisphere stroke in clinical imaging (CT/MRI) and NIHSS
• Participants must have spoken English as their primary language.
• 21-81 years old
• Pre-stroke modified Rankin Scale (mRS)= 2 or less
• Post-stroke mRS= 4 or less.
• At least 6 months post-stroke.
• Non-fluent aphasia (WAB-R Comprehension score >4 and WAB-R Fluency score <6).
• Technological compatibility (to be determined by clinical judgment of SLP)

Exclusion Criteria

• History of chronic neurological or psychiatric diseases (excluding migraines, depression, or post-stroke epilepsy). Self-reported history of learning disability.
• Severe dysarthria (determined via SLP clinical judgment from spontaneous speech tasks on the ASRS 3.0).
• Global aphasia.
• History of right-hemisphere strokes or brain stem/cerebellar strokes with persistent deficits (as evidenced by MRI/CT and NIHSS).
• Uncorrectable hearing as determined by the SLP's clinical judgment.
• Uncorrectable vision.
• Contraindications to MRI or inability to complete the MRI scanning session.
• Women who are pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SET (Speech Entrainment Therapy) 3 weeks	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
Experimental: SET (Speech Entrainment Therapy) 4.5 weeks	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
Experimental: SET (Speech Entrainment Therapy) 6 weeks	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	Other: No Therapy 6 Weeks; Participants will not be getting any SET for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Verbs Per Minute (VPM) in Speech Sample	VPM will be assessed through procedural storytelling and narrative story telling 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.	3 months after treatment (or no treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)	We will estimate the dose of SET for individuals with non-fluent aphasia that has the highest effect size on SAQOL-39g.	3 months after treatment (or no treatment)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Leonardo Bonilha, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Therapy; Aphasia; Speech Language Pathology
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 00091924; U01DC017521-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No