Modeling Treated Recovery From Aphasia

NCT ID: NCT03416738

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-02

Study Completion Date

2021-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Semantically focused treatment

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

Group Type ACTIVE_COMPARATOR

Semantically focused treatment

Intervention Type BEHAVIORAL

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.

Phonologically focused treatment

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

Group Type ACTIVE_COMPARATOR

Phonologically focused treatment

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Julius Fridriksson

Endowed Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julius Fridriksson, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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Busby N, Wilmskoetter J, Gleichgerrcht E, Rorden C, Roth R, Newman-Norlund R, Hillis AE, Keller SS, de Bezenac C, Kristinsson S, Fridriksson J, Bonilha L. Advanced Brain Age and Chronic Poststroke Aphasia Severity. Neurology. 2023 Mar 14;100(11):e1166-e1176. doi: 10.1212/WNL.0000000000201693. Epub 2022 Dec 16.

Reference Type DERIVED
PMID: 36526425 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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P50DC014664

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00053559

Identifier Type: -

Identifier Source: org_study_id

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