- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05980897
Inner Speech and Naming Treatment for Individuals with Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aphasia, a language disorder commonly acquired through stroke, has chronic negative impacts on communication abilities and quality of life. The specific language deficits associated with aphasia typically vary from person to person, but a universal element of aphasia is anomia, or difficulty with naming and word-finding. It is well-known that individuals with aphasia struggle to convey their ideas through overt speech, but little is known about this population's ability to access and utilize inner speech (IS). IS can be defined in many ways, but one simple definition that is well known to most language users is the mental imagery of having a little voice in one's head. Importantly, individuals with aphasia often endorse a mismatch between this "little voice" (IS) and what they can actually say out loud. In a prior interview-based study, over 75% of individuals with aphasia endorsed the specific experience of being able to say a word in their head despite being unable to say it aloud.
Previous research examined whether self-reported "successful IS" (sIS) (i.e., I can say the word in my head and it sounds right) predicted therapy outcomes in two participants. In both participants, self-reported IS predicted whether or not (and how quickly) individual words were successfully re-learned during a paired-associate treatment for anomia, and the effect was visible within just a few treatment sessions. This trial provides preliminary evidence that IS can be leveraged to improve outcomes of naming therapy for individuals with aphasia. This study aims to extend these prior finding by implementing a behavioral treatment for anomia using a single-subject experimental design in a larger group of individuals with aphasia.
The investigators predict that items reported as sIS will be more effectively learned during anomia treatment than items that are reported as uIS. Because sIS items are already being retrieved by the individual, one can think of them as being closer to successful spoken output than items that are not able to be retrieved (i.e., those reported as uIS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20052
- The George Washington University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Naming Treatment
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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Naming accuracy for sIS vs. uIS items (of 100%)
Time Frame: 5 weeks
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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.
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5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall naming accuracy (of 100%)
Time Frame: 5 weeks
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A comparison of pre-treatment (average of three baseline sessions) to post-treatment spoken naming (40 items) across participants
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5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mackenzie Fama, The George Washington University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCR224453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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