AphasiaNCT05980897
Inner Speech and Naming Treatment for Individuals with Aphasia
A study testing Naming treatment in people with Aphasia and Anomia, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Anomia, Language Disorders
- What is being tested?
- Naming treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University
Washington D.C., District of Columbia, 20052
About this study
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.
Read the 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).
- Conditions
- Aphasia, Anomia, Language Disorders, Communication Disorders
- Being tested
- Naming treatment
- Keywords
- Aphasia, Anomia, Speech-Language Pathology, Speech Therapy, Inner Speech
- Medical subject headings
- Aphasia, Anomia, Language Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naming treatmentBehavioural
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:
- Name the picture independently
- Name the picture with a written cue
- Repeat the name of the picture
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Naming treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (1)
Overall naming accuracy (of 100%)
A comparison of pre-treatment (average of three baseline sessions) to post-treatment spoken naming (40 items) across participants
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start5 Jul 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Alternating treatment single-subject experimental design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mackenzie Fama, George Washington University
- Investigators
- Mackenzie Fama, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980897
- Sponsor's protocol ID
- NCR224453
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data and/or testing materials with interested researchers, educators or clinicians upon request.
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.
PubMed 27694017Fama 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.
PubMed 30950758Fama 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.
PubMed 30921682Fama 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.
PubMed 31518502Hayward 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.
PubMed 27469037
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inner Speech and Naming Treatment for Individuals with Aphasia
- ClinicalTrials.gov ID
- NCT05980897
- Acronym / sponsor ID
- NCR224453
- Conditions
- Aphasia, Anomia, Language Disorders, Communication Disorders
- Keywords
- Aphasia, Anomia, Speech-Language Pathology, Speech Therapy, Inner Speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Alternating treatment single-subject experimental design
| Arm | Type | Receives |
|---|---|---|
| Naming Treatment | Experimental | Behavioral: Naming treatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naming treatmentIn 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. | Behavioural | Naming Treatment |
Primary outcome
Naming accuracy for sIS vs. uIS items (of 100%)
Time frame: 5 weeks
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.
1 secondary outcome
Overall naming accuracy (of 100%)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 27694017Fama 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.
- Background: PubMed 30950758Fama 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.
- Background: PubMed 30921682Fama 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.
- Background: PubMed 31518502Fama 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.
- Background: PubMed 27469037Hayward 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.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data and/or testing materials with interested researchers, educators or clinicians upon request.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mackenzie Fama principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naming treatment in people with Aphasia and Anomia, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naming accuracy for sIS vs. uIS items (of 100%) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980897, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.