search
Back to results

Speech Entrainment for Aphasia Recovery (SpARc)

Primary Purpose

Aphasia, Aphasia Non Fluent, Stroke

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SET (Speech Entrainment Therapy) 3 weeks
SET (Speech Entrainment Therapy) 4.5 weeks
SET (Speech Entrainment Therapy) 6 weeks
No Therapy 6 Weeks
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Speech Language Pathology, Therapy

Eligibility Criteria

21 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South CarolinaRecruiting
  • University of South CarolinaRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

SET (Speech Entrainment Therapy) 3 weeks

SET (Speech Entrainment Therapy) 4.5 weeks

SET (Speech Entrainment Therapy) 6 weeks

No Therapy 6 weeks

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 23, 2020
Last Updated
June 26, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
search

1. Study Identification

Unique Protocol Identification Number
NCT04364854
Brief Title
Speech Entrainment for Aphasia Recovery
Acronym
SpARc
Official Title
Speech Entrainment for Aphasia Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Aphasia Non Fluent, Stroke
Keywords
Aphasia, Speech Language Pathology, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SET (Speech Entrainment Therapy) 3 weeks
Arm Type
Experimental
Arm Title
SET (Speech Entrainment Therapy) 4.5 weeks
Arm Type
Experimental
Arm Title
SET (Speech Entrainment Therapy) 6 weeks
Arm Type
Experimental
Arm Title
No Therapy 6 weeks
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
SET (Speech Entrainment Therapy) 3 weeks
Intervention Description
3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
Intervention Type
Behavioral
Intervention Name(s)
SET (Speech Entrainment Therapy) 4.5 weeks
Intervention Description
4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
Intervention Type
Behavioral
Intervention Name(s)
SET (Speech Entrainment Therapy) 6 weeks
Intervention Description
6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
Intervention Type
Other
Intervention Name(s)
No Therapy 6 Weeks
Intervention Description
Participants will not be getting any SET for 6 weeks
Primary Outcome Measure Information:
Title
Number of Verbs Per Minute (VPM) in Speech Sample
Description
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.
Time Frame
3 months after treatment (or no treatment)
Secondary Outcome Measure Information:
Title
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Description
We will estimate the dose of SET for individuals with non-fluent aphasia that has the highest effect size on SAQOL-39g.
Time Frame
3 months after treatment (or no treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Cute, CCC-SLP
Phone
(843) 792-3678
Email
cute@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Krajeck, MHA
Phone
(843) 792-0189
Email
krajeck@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Bonilha, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Cute, CCC-SLP
Phone
843-792-3678
Email
cute@musc.edu
First Name & Middle Initial & Last Name & Degree
Janina Wilmskoetter, PhD
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Aitchison, PhD
Phone
803-777-5905
Email
mjaitchi@mailbox.sc.edu
First Name & Middle Initial & Last Name & Degree
Julius Fridriksson, PhD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Wambaugh, PhD
Phone
801-585-6164
Email
julie.wambaugh@health.utah.edu
First Name & Middle Initial & Last Name & Degree
Robert Kraemer, PhD
First Name & Middle Initial & Last Name & Degree
Julie Wambaugh, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Speech Entrainment for Aphasia Recovery

We'll reach out to this number within 24 hrs