AphasiaNCT04267198
Intention Treatment for Anomia
A study testing Intention Treatment for Anomia in people with Aphasia and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Every year approximately 15,000 Veterans are hospitalized for stroke, and up to 40% of those Veterans will experience stroke-related language impairment (i.e., aphasia). Stroke-induced aphasia results in increased healthcare costs and decreased quality of life. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- What is being tested?
- Intention Treatment for Anomia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 30 Sep 2025
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English as primary language
- > 6 months post-onset a left-hemisphere stroke. Multiple strokes are acceptable as long as they are confined to the left hemisphere.
- Diagnosis of aphasia
- Presence of word retrieval deficits
- Adequate comprehension as judged by ability to complete two-step commands on the Western Aphasia Battery.
Who cannot join
- Severe apraxia of speech or dysarthria
- Clinically significant depression
- For MRI safety: implanted medical devices, metal in the body and claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
About this study
Official title: Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation
Every year approximately 15,000 Veterans are hospitalized for stroke, and up to 40% of those Veterans will experience stroke-related language impairment (i.e., aphasia). Stroke-induced aphasia results in increased healthcare costs and decreased quality of life. As the population of Veterans continues to age, there will be an increasing number for Veterans living with the aphasia and its consequences. Those Veterans deserve to receive aphasia treatment designed to facilitate the best possible outcomes. In the proposed study, the investigators will investigate optimal treatment intensity and predictors of treatment response for a novel word retrieval treatment. The knowledge the investigators gain will have direct implications for the selecting the right treatment approach for the right Veteran.
Read the detailed description
Difficulty retrieving words is one of the most common language complaints in individuals with stroke-induced aphasia. The negative consequences related to word retrieval impairment include increased health care costs and decreased quality of life. A variety of treatment approaches exist to improve word retrieval, and most of the treatments result in immediate improvement on trained words. However, long-term improvement and improvement on untrained words or behaviors is less common. Additionally, the investigators currently know very little about optimal treatment administration parameters, and the investigators know even less about predictors of treatment response. To make the best use of the limited clinical resources available for aphasia treatment, and to maximize outcomes for Veterans with aphasia, the investigators must: 1) develop clinically translatable treatments that yield widespread and lasting effects and 2) develop clinically accessible ways of identifying who will acquire benefit from a specific treatment approach. This study takes on these two challenges by investigating dose frequency (massed vs. distributed practice) effects and by identifying the language, cognitive and neural predictors of response to Intention treatment (INT), a novel word retrieval treatment. Specifically, the investigators will address the following aims:
Aim 1: To investigate dose frequency effects on maintenance and generalization of INT gains. Outcome measure: Word retrieval accuracy for trained and untrained words.
Aim 2: To identify the language and cognitive variables that predict response to m-INT vs. d-INT. Outcome measure: Language and cognitive ability as measured by standardized assessments.
Aim 3: To identify the neural predictors of response to m-INT vs. d-INT. Outcome measure: Tissue health and task activation location as measured by structural and functional MRI.
- Being tested
- Intention Treatment for Anomia
- Keywords
- aphasia, language, rehabilitation, speech-language pathology
- Medical subject headings
- Aphasia, Stroke, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intention Treatment for AnomiaBehavioural
Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.
| Study group | Role | What they receive |
|---|---|---|
| Massed Intention Treatment (massed-INT) | Active comparator | Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks. Receives: Behavioral: Intention Treatment for Anomia |
| Distributed Intention Treatment (distributed-INT) | Active comparator | Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks. Receives: Behavioral: Intention Treatment for Anomia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correctly named pictures
Change in the ability to correctly name 10 trained and 10 untrained pictures will be measured at 4 time points
Measured: Through study completion, an average of 6 months; Change from baseline to 3 weeks (post massed-INT) or 12 weeks (post distributed-INT), change at 3 months post-treatment, change at 6 months post-treatment
Number of correctly generated category members
Change in the ability to correctly name 5 trained and 5 untrained category members will be measured at 4 time points
Measured: Through study study completion, an average of 6 months; Change from baseline to 3 weeks (post m-INT) or 12 weeks (post d-INT), change at 3 months post-treatment, change at 6 months post-treatment
Western Aphasia Battery
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Measured: Baseline
Boston Naming Test
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Measured: Baseline
Test of Everyday Attention
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Measured: Baseline
Brief Visuospatial Memory Test-Revised
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Measured: Baseline
Hopkins Verbal Learning Test-Revised
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Measured: Baseline
Digit Span Backwards
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Measured: Baseline
Delis-Kaplan Executive Function System (D-KEFS) Sorting
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Measured: Baseline
Structural MRI scan
Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.
Measured: Baseline
Functional MRI scan
Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.
Measured: Baseline
Secondary outcomes (1)
Delis-Kaplan Executive Function System (D-KEFS) Trails
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start24 May 2021
- Primary completion31 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy D. Rodriguez, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267198
- Sponsor's protocol ID
- N3093-R
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2020
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation
- ClinicalTrials.gov ID
- NCT04267198
- Acronym / sponsor ID
- N3093-R
- Keywords
- aphasia, language, rehabilitation, speech-language pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 May 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 12 Feb 2020 (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.
Every year approximately 15,000 Veterans are hospitalized for stroke, and up to 40% of those Veterans will experience stroke-related language impairment (i.e., aphasia). Stroke-induced aphasia results in increased healthcare costs and decreased quality of life. As the population of Veterans continues to age, there will be an increasing number for Veterans living with the aphasia and its consequences. Those Veterans deserve to receive aphasia treatment designed to facilitate the best possible outcomes. In the proposed study, the investigators will investigate optimal treatment intensity and predictors of treatment response for a novel word retrieval treatment. The knowledge the investigators gain will have direct implications for the selecting the right treatment approach for the right Veteran.
Detailed description
Difficulty retrieving words is one of the most common language complaints in individuals with stroke-induced aphasia. The negative consequences related to word retrieval impairment include increased health care costs and decreased quality of life. A variety of treatment approaches exist to improve word retrieval, and most of the treatments result in immediate improvement on trained words. However, long-term improvement and improvement on untrained words or behaviors is less common. Additionally, the investigators currently know very little about optimal treatment administration parameters, and the investigators know even less about predictors of treatment response. To make the best use of the limited clinical resources available for aphasia treatment, and to maximize outcomes for Veterans with aphasia, the investigators must: 1) develop clinically translatable treatments that yield widespread and lasting effects and 2) develop clinically accessible ways of identifying who will acquire benefit from a specific treatment approach. This study takes on these two challenges by investigating dose frequency (massed vs. distributed practice) effects and by identifying the language, cognitive and neural predictors of response to Intention treatment (INT), a novel word retrieval treatment. Specifically, the investigators will address the following aims:
Aim 1: To investigate dose frequency effects on maintenance and generalization of INT gains. Outcome measure: Word retrieval accuracy for trained and untrained words.
Aim 2: To identify the language and cognitive variables that predict response to m-INT vs. d-INT. Outcome measure: Language and cognitive ability as measured by standardized assessments.
Aim 3: To identify the neural predictors of response to m-INT vs. d-INT. Outcome measure: Tissue health and task activation location as measured by structural and functional MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.
| Arm | Type | Receives |
|---|---|---|
| Massed Intention Treatment (massed-INT) | Active comparator | Behavioral: Intention Treatment for AnomiaParticipants will receive 30 hours of Intention Treatment (INT) over 3 weeks. |
| Distributed Intention Treatment (distributed-INT) | Active comparator | Behavioral: Intention Treatment for AnomiaParticipants will receive 30 hours of Intention Treatment (INT) over 12 weeks. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English as primary language
- > 6 months post-onset a left-hemisphere stroke. Multiple strokes are acceptable as long as they are confined to the left hemisphere.
- Diagnosis of aphasia
- Presence of word retrieval deficits
- Adequate comprehension as judged by ability to complete two-step commands on the Western Aphasia Battery.
Key exclusion criteria (3 listed)
- Severe apraxia of speech or dysarthria
- Clinically significant depression
- For MRI safety: implanted medical devices, metal in the body and claustrophobia.
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 |
|---|---|---|
| Intention Treatment for AnomiaWord retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture. | Behavioural | Distributed Intention Treatment (distributed-INT), Massed Intention Treatment (massed-INT) |
Primary outcome
Number of correctly named pictures
Time frame: Through study completion, an average of 6 months; Change from baseline to 3 weeks (post massed-INT) or 12 weeks (post distributed-INT), change at 3 months post-treatment, change at 6 months post-treatment
Change in the ability to correctly name 10 trained and 10 untrained pictures will be measured at 4 time points
Number of correctly generated category members
Time frame: Through study study completion, an average of 6 months; Change from baseline to 3 weeks (post m-INT) or 12 weeks (post d-INT), change at 3 months post-treatment, change at 6 months post-treatment
Change in the ability to correctly name 5 trained and 5 untrained category members will be measured at 4 time points
Western Aphasia Battery
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Boston Naming Test
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Test of Everyday Attention
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Brief Visuospatial Memory Test-Revised
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Hopkins Verbal Learning Test-Revised
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Digit Span Backwards
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Delis-Kaplan Executive Function System (D-KEFS) Sorting
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Structural MRI scan
Time frame: Baseline
Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.
Functional MRI scan
Time frame: Baseline
Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.
1 secondary outcome
Delis-Kaplan Executive Function System (D-KEFS) Trails
Time frame: Baseline
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 22 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Amy D. Rodriguez, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intention Treatment for Anomia in people with Aphasia and Stroke, run by VA Office of Research and Development 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 3 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 22 Oct 2025. 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?
Number of correctly named pictures (time frame: Through study completion, an average of 6 months; Change from baseline to 3 weeks (post massed-INT) or 12 weeks (post distributed-INT), change at 3 months post-treatment, change at 6 months post-treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2025.