NCT05980897

Brief Summary

Aphasia is a language disorder, commonly resulting from stroke or other brain injury, that impacts a person's ability to communicate. This project is looking to improve upon current treatment methods for spoken naming in people with aphasia. People with aphasia frequently report being able to successfully say a word in their head, regardless of their ability to say the word out loud. For example, when presented with a picture of a house, they may report being able to think or hear "house" in their head, even if they can't name it out loud. This "little voice" inside one's head is known as inner speech (IS). Previous research suggests that some people with aphasia can re-learn to say words with successful IS (i.e., words they can already say in their heads) easier and faster than words with unsuccessful IS. This study will extend these findings by implementing a comparative treatment study in a larger group of participants with aphasia. The results will help to establish recommendations for speech-language pathologists in choosing treatment stimuli for anomia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

July 21, 2023

Last Update Submit

September 23, 2024

Conditions

Keywords

AphasiaAnomiaSpeech-Language PathologySpeech TherapyInner Speech

Outcome Measures

Primary Outcomes (1)

  • Naming accuracy for sIS vs. uIS items (of 100%)

    A direct comparison of treatment response for successful inner speech (sIS) vs. unsuccessful inner speech (uIS) items, measured via accuracy on a spoken naming test.

    5 weeks

Secondary Outcomes (1)

  • Overall naming accuracy (of 100%)

    5 weeks

Study Arms (1)

Naming Treatment

EXPERIMENTAL

Participants will complete three sessions of baseline probe testing (40 treatment items) occurring virtually on three consecutive days prior to treatment onset. Participants will then complete 10 sessions of therapy scheduled five days a week for two weeks, all occurring virtually. The treatment approach for this study will be a hierarchical, cueing-based treatment for naming.

Behavioral: Naming treatment

Interventions

In this alternating treatment single-subject experimental design study, the investigators will alternate between two treatment conditions, i.e., two different types of stimulus items: those that are consistently reported as successful IS prior to treatment (sIS items) and those that are consistently reported as unsuccessful IS prior to treatment (uIS items). The treatment will be computerized to ensure consistency of presentation, timing, and cues across participants. For each stimulus presentation, the treatment hierarchy will proceed as follows: 1. Name the picture independently 2. Name the picture with a written cue 3. Repeat the name of the picture 4. Name the picture after a 5 second delay Each participant will be trained on a set of 40 items chosen specifically for them based on initial/baseline testing.

Naming Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have aphasia resulting from stroke occurring at least 6 months ago
  • Are at least 18 years old
  • Learned English at age 5 years or younger
  • Normal or corrected-to-normal hearing and vision
  • Have access to reliable internet at home for remote participation

You may not qualify if:

  • Have a history of other brain conditions that could impact interpretation of results (such as Parkinson's Disease or dementia)
  • Have a history of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Related Publications (5)

  • Fama ME, Hayward W, Snider SF, Friedman RB, Turkeltaub PE. Subjective experience of inner speech in aphasia: Preliminary behavioral relationships and neural correlates. Brain Lang. 2017 Jan;164:32-42. doi: 10.1016/j.bandl.2016.09.009. Epub 2016 Sep 29.

    PMID: 27694017BACKGROUND
  • Fama ME, Snider SF, Henderson MP, Hayward W, Friedman RB, Turkeltaub PE. The Subjective Experience of Inner Speech in Aphasia Is a Meaningful Reflection of Lexical Retrieval. J Speech Lang Hear Res. 2019 Jan 30;62(1):106-122. doi: 10.1044/2018_JSLHR-L-18-0222.

    PMID: 30950758BACKGROUND
  • Fama ME, Henderson MP, Snider SF, Hayward W, Friedman RB, Turkeltaub PE. Self-reported inner speech relates to phonological retrieval ability in people with aphasia. Conscious Cogn. 2019 May;71:18-29. doi: 10.1016/j.concog.2019.03.005. Epub 2019 Mar 25.

    PMID: 30921682BACKGROUND
  • Fama ME, Turkeltaub PE. Inner Speech in Aphasia: Current Evidence, Clinical Implications, and Future Directions. Am J Speech Lang Pathol. 2020 Feb 21;29(1S):560-573. doi: 10.1044/2019_AJSLP-CAC48-18-0212. Epub 2019 Sep 13.

    PMID: 31518502BACKGROUND
  • Hayward W, Snider SF, Luta G, Friedman RB, Turkeltaub PE. Objective support for subjective reports of successful inner speech in two people with aphasia. Cogn Neuropsychol. 2016 Jul-Sep;33(5-6):299-314. doi: 10.1080/02643294.2016.1192998. Epub 2016 Jul 29.

    PMID: 27469037BACKGROUND

MeSH Terms

Conditions

AphasiaAnomiaLanguage DisordersCommunication Disorders

Condition Hierarchy (Ancestors)

Speech DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mackenzie Fama

    The George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Alternating treatment single-subject experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 8, 2023

Study Start

July 5, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Investigators will share de-identified data and/or testing materials with interested researchers, educators or clinicians upon request.

Time Frame
Data will be made accessible at the time of initial publication.
Access Criteria
Access to participant data by an external researcher may require a formal data sharing agreement with that researcher's institution.

Locations