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Modeling Treated Recovery From Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416738
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : April 28, 2022
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Julius Fridriksson, University of South Carolina

Study Description
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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.


Condition or disease Intervention/treatment Phase
Aphasia Stroke Stroke, Ischemic Aphasia, Broca Aphasia, Global Aphasia, Mixed Aphasia, Jargon Aphasia, Expressive Aphasia, Conduction Aphasia, Fluent Aphasia, Anomic Behavioral: Semantically focused treatment Behavioral: Phonologically focused treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: (C-STAR) Center for the Study of Aphasia Recovery Modeling Treated Recovery From Aphasia
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : May 30, 2021
Actual Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Semantically focused treatment
This treatment will focus on improving word finding and comprehension of information.
 Behavioral: Semantically focused treatment

Tasks are as follows:

  1. 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.
  2. 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.
  3. 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.
Active Comparator: Phonologically focused treatment
This treatment will focus on training speech sound production, targeting overall production abilities.
 Behavioral: Phonologically focused treatment

Tasks are as follows:

  1. 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).
  2. 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.
  3. 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.


Outcome Measures
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Primary Outcome Measures :
  1. Philadelphia Naming Test [ Time Frame: 6 months ]
    Assesses the ability to name functional objects


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416738


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Julius Fridriksson, PhD, CCC-SLP University of South Carolina
  Study Documents (Full-Text)

Documents provided by Julius Fridriksson, University of South Carolina:
Study Protocol and Statistical Analysis Plan  [PDF] April 20, 2020

More Information
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Additional Information:

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Responsible Party: Julius Fridriksson, Endowed Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT03416738    
Other Study ID Numbers: Pro00053559
P50DC014664 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Aphasia
Ischemic Stroke
Aphasia, Broca
Anomia
Aphasia, Wernicke
Aphasia, Conduction
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations