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CompletedNCT03416738Updated Apr 28, 2022

Modeling Treated Recovery From Aphasia

An interventional study of Semantically focused treatment and Phonologically focused treatment in Aphasia, Stroke and Stroke, Ischemic, sponsored by University of South Carolina. Completed at 2 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-28.

Sponsored by University of South Carolina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aphasia
  • Stroke
  • Stroke, Ischemic
  • Aphasia, Broca
  • Aphasia, Global
  • Aphasia, Mixed
  • Aphasia, Jargon
  • Aphasia, Expressive
  • Aphasia, Conduction
  • Aphasia, Fluent
  • Aphasia, Anomic
03

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • Active comparator
    Semantically focused treatment

    This treatment will focus on improving word finding and comprehension of information.

    Behavioral: Semantically focused treatment

  • Active comparator
    Phonologically focused treatment

    This treatment will focus on training speech sound production, targeting overall production abilities.

    Behavioral: Phonologically focused treatment

Interventions

  • BehavioralSemantically 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.

  • BehavioralPhonologically 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.

05

What researchers measure

Primary outcomes

  1. Philadelphia Naming Test

    Assesses the ability to name functional objects

    Time frame: 6 months

06

Study locations

2 sites
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of South Carolina
    Columbia, South Carolina 29208, United States
07

References and documents

Related links

Study documents

  • Protocol and statistical analysis plan · Apr 20, 2020

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03416738
Lead sponsor
University of South Carolina
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Julius Fridriksson (Endowed Professor, University of South Carolina) — Principal investigator
First posted
Jan 31, 2018
Start date
Aug 2, 2016
Primary completion
May 30, 2021
Completion
May 30, 2021
Last update
Apr 28, 2022

Study contacts

Julius Fridriksson, PhD, CCC-SLP
principal investigator · University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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