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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03416738
Other study ID # Pro00053559
Secondary ID P50DC014664
Status Completed
Phase N/A
First received
Last updated
Start date August 2, 2016
Est. completion date May 30, 2021

Study information

Verified date April 2022
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Semantically focused treatment
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.
Phonologically focused treatment
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.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States University of South Carolina Columbia South Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of South Carolina National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Philadelphia Naming Test Assesses the ability to name functional objects 6 months
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