An interventional study of Naming treatment in Aphasia, Anomia and Language Disorders, sponsored by George Washington University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by George Washington University · Not applicable, Interventional, and Treatment
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.
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).
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
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Exclusion Criteria:
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
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 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.
Time frame: 5 weeks
Overall naming accuracy (of 100%)
A comparison of pre-treatment (average of three baseline sessions) to post-treatment spoken naming (40 items) across participants
Time frame: 5 weeks
Plan to share: Yes — 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.
Ran from Jul 2023 to primary completion in May 2024, 9 months.
Of 183 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's 9 months is below that.
Counting every sponsor, half of 185 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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