Modeling Treated Recovery From Aphasia
Primary Purpose
Aphasia, Stroke, Stroke, Ischemic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Semantically focused treatment
Phonologically focused treatment
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia
Eligibility Criteria
Inclusion Criteria:
- Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke
- Primarily English speaker for the past 20 years
- Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic)
Exclusion Criteria:
- History of a right hemisphere stroke (Bilateral stroke)
- Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
- Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided
Sites / Locations
- Medical University of South Carolina
- University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Semantically focused treatment
Phonologically focused treatment
Arm Description
This treatment will focus on improving word finding and comprehension of information.
This treatment will focus on training speech sound production, targeting overall production abilities.
Outcomes
Primary Outcome Measures
Philadelphia Naming Test
Assesses the ability to name functional objects
Secondary Outcome Measures
Full Information
NCT ID
NCT03416738
First Posted
January 23, 2018
Last Updated
April 27, 2022
Sponsor
University of South Carolina
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03416738
Brief Title
Modeling Treated Recovery From Aphasia
Official Title
(C-STAR) Center for the Study of Aphasia Recovery Modeling Treated Recovery From Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
Stroke is the leading cause of adult disability in the United States, and aphasia is common following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia recover; however, very little is known about how different patients respond to different types of treatments.
The purpose of this study is to understand how the following factors influence an individual's response to aphasia treatment: 1) biographical factors (e.g., age, education, gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the location and extent of post-stroke brain damage. We are also interested in understanding the kinds of treatment materials that should be emphasized in speech/language treatment.
Overall, the goal of the current research is to inform the clinical management of post-stroke aphasia by identifying factors that can predict how an individual will respond to different treatment methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke, Stroke, Ischemic, Aphasia, Broca, Aphasia, Global, Aphasia, Mixed, Aphasia, Jargon, Aphasia, Expressive, Aphasia, Conduction, Aphasia, Fluent, Aphasia, Anomic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semantically focused treatment
Arm Type
Active Comparator
Arm Description
This treatment will focus on improving word finding and comprehension of information.
Arm Title
Phonologically focused treatment
Arm Type
Active Comparator
Arm Description
This treatment will focus on training speech sound production, targeting overall production abilities.
Intervention Type
Behavioral
Intervention Name(s)
Semantically focused treatment
Intervention Description
Tasks are as follows:
Semantic feature analysis (SFA): For each pictured stimulus the patient is prompted to name the picture, and then to produce related words that represent features similar to the target word.
Semantic barrier task: The goal is for one participant (e.g., patient) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. Participants are only allowed to describe the semantic features of the target and the clinician models the kinds of cues that are allowed.
Verb network strengthening treatment (VNeST): This treatment targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the patient to generate verb-noun associates with the purpose of strengthening the connections between the verb and its uses.
These are tasks used in clinical aphasia rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Phonologically focused treatment
Intervention Description
Tasks are as follows:
Phonological (sound) components analysis task: Participants are to name a given picture and then to identify the sound features of the target words (e.g., first sound, last sound, and rhyme).
Phonological production task: This tasks asks participants to sort and identify the sounds that make up a word. Various stages include identifying first sounds, last sounds, etc. Participants also work on blending sounds together to form words.
The phonological judgment task: A computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features.
These are tasks used in clinical aphasia rehabilitation.
Primary Outcome Measure Information:
Title
Philadelphia Naming Test
Description
Assesses the ability to name functional objects
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke
Primarily English speaker for the past 20 years
Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic)
Exclusion Criteria:
History of a right hemisphere stroke (Bilateral stroke)
Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius Fridriksson, PhD, CCC-SLP
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cstar.sc.edu
Description
Study website
Learn more about this trial
Modeling Treated Recovery From Aphasia
We'll reach out to this number within 24 hrs