NCT03416738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4.8 years

First QC Date

January 23, 2018

Last Update Submit

April 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Philadelphia Naming Test

    Assesses the ability to name functional objects

    6 months

Study Arms (2)

Semantically focused treatment

ACTIVE COMPARATOR

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

Behavioral: Semantically focused treatment

Phonologically focused treatment

ACTIVE COMPARATOR

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

Behavioral: Phonologically focused treatment

Interventions

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.

Semantically 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.

Phonologically focused treatment

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

AphasiaStrokeIschemic StrokeAphasia, BrocaAphasia, WernickeAphasia, ConductionAnomia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Julius Fridriksson, PhD, CCC-SLP

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endowed Professor

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 31, 2018

Study Start

August 2, 2016

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations