Post-stroke AphasiaNAILNCT04081207
Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia
A study testing AAC for Language Recovery (AAC-LaRc) in people with Post-stroke Aphasia and Aphasia, run by University of Cincinnati at 1 site in United States.
Trial summary
The currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. This study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Aphasia, Aphasia
- What is being tested?
- AAC for Language Recovery (AAC-LaRc)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to Dec 2021
- 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
- at least 18 years old
- native speaker of american English
- compatible for 3 Tesla MRI
- Ischemic, left middle cerebral artery stroke
- at least 12 months post stroke
- pass hearing screening
Show all 12Show fewer
- pass vision screening
- diagnosis of aphasia on the Western Aphasia Bedside Screen
- ability to produce 5-10 intelligible words
- no more than a moderate apraxia of speech or dysarthria
- minimal or no AAC/iPad experience
- written consent by self or guardian
Who cannot join
- fails to meet the above
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Report of pregnancy by women of childbearing age
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Aimee Dietz, PhD, 513-558-8551, aimee.dietz@uc.edu
Jennifer Vannest, BS, 513-558-85418 ext. Dietz, aimee.dietz@uc.edu
About this study
Official title: A Preliminary Study of the Neurobiology of AAC-Induced Language Recovery in Post-Stroke Aphasia
The currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. This study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. Further, this project will help us identify regions of the brain responsible for these changes.
Read the detailed description
In aphasia rehabilitation, usual care is focused on helping people recuperate as much of their pre-stroke language capacity as possible.Typically, usual care is a non-standardized therapy that is tailored to the specific needs of the person with aphasia.Once a person reaches a plateau in language recovery, AAC is implemented with a focus on circumventing, or compensating for the communication challenges associated with aphasia.
The ability of people with aphasia to (1) recover language function well-into the chronic phase of stroke recovery and (2) self-cue to promote word retrieval during anomic events offer the solution for how AAC could be employed as a dual-purpose tool to augment language recovery and compensate for deficits. This approach, however, this requires a shift in how AAC is implemented. With the goal of language recovery, treatment needs to focus on instructing people with aphasia how to use AAC as a mechanism for self-cueing, rather than as a tool to replace speaking. Based on our pilot data, we hypothesize that this novel method to AAC implementation will promote language recovery by coupling the canonical language and visual processing neural networks.
This work will also contribute to our ability to identify, a priori, who will respond to this particular AAC intervention and who will not, by combining neuroimaging with behavioral and clinical data. This has the potential to reduce the cost of healthcare for stroke recovery by implementing the most effective treatment possible. Importantly, when we identify non-responders, this will allow us to construct a profile and identify features of the AAC treatment that require adjustment to meet their unique needs.
- Conditions
- Post-stroke Aphasia, Aphasia
- Being tested
- AAC for Language Recovery (AAC-LaRc)
- Keywords
- augmentative and alternative communication, aphasia, fMRI, DTI, neuroimaging
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAC for Language Recovery (AAC-LaRc)Behavioural
iPads will be programmed with a personalized communication application (app) and a structured 4-step intervention will be employed to instruct patients how to cue themselves during anomic events via pictures, text, or speak buttons.
| Study group | Role | What they receive |
|---|---|---|
| AAC-LaRc | Experimental | all participants receive the experimental treatment Receives: Behavioral: AAC for Language Recovery (AAC-LaRc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Aphasia Battery-Revised Aphasia Quotient
a diagnostic tool used to determine aphasia type and severity
Measured: 3 years
Visual Regions of Interest Activation intensity
A functional magnetic resonance imaging (fMRI) measure to indicate change in brain involvement during resting state and language tasks.
Measured: 3 years
Connectivity Indices
Connectivity indices reflect the temporal correlation between canonical language and visual regions of interest during language and resting state fMRI tasks.
Measured: 3 years
Secondary outcomes (8)
Motor-Free Visual Perception Test-4
The Motor-Free Visual Perception Test-4 assesses visual perceptual ability without requiring motor responses.
Measured: 3 years
Discourse Analyses
We will calculate percentage of counted words, mazes, correct information units, t-units, during personal story retells with and without the AAC support.
Measured: 3years
Communication analyses
We will calculate percentage of communication conveyed via pictures, text boxes, and speak button during personal story retells with and without the iPad AAC support.
Measured: 3 years
Stroke and Aphasia Quality of Life-39 (SAQOL-39)
The SAQOL-39 is a valid and reliable measure of health related quality of life, post-stroke that uses an aphasia friendly 5 point Likert scale format.
Measured: 3 years
Communication Effectiveness Index (CETI)
The CETI measures functional communication scenarios that caregivers rate the ability of the patient to complete tasks, as compared to before their stroke, via a 10 cm visual analogue scale.
Measured: 3 years
Fractional Anisotropy (FA)
FA is a value of diffusion and reflects white matter density and myelination. We will examine the following tracts: (1) superior, (2) inferior fronto-occipital, (3) middle longitudinal, (4) inferior longitudinal fasciculus, (5) arcuate, and (6) uncinate
Measured: 3 years
Mean Diffusivity (MD)
MD is used to map tracts and serves as a measure of health or disease in white matter. We will determine the MD for the following pathways: (1) superior, (2) inferior fronto-occipital, (3) middle longitudinal, (4) inferior longitudinal fasciculus, (5) arcuate, and (6) uncinate
Measured: 3 years
Language Lateralization Indices (LI)
LI is a measure that reflects hemispheric dominance for language, while accounting for lesioned tissue.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Sep 2018
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke AphasiaStudies of the same condition, open and under way.
- 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
- Participant cohorts: We will use a 2 (groups) X 4 (measurement time points) switching replications design\[18\] to examine the effects of AAC on aphasia severity and spoken language (AIM 1), elucidate the neurobiological mechanism of AAC-induced language recovery (AIM 2), and identify AAC treatment responder subgroups (Exploratory Aim). This design will allow Group 2 to serve as the control group; however, they will still receive AAC treatment; thus, allowing us to increase the total N who receives AAC treatment to 20 people.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Aimee Dietz, University of Cincinnati
- Investigators
- Aimee Dietz, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081207
- Sponsor's protocol ID
- 1R15DC017280-01
- Acronym
- NAIL
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects based on their private health information and language profiles. Further, it is possible to reconstruct faces from MRI data and the patients are easily identified through the testing and treatment videos; thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be shared at the time of publication, or shortly thereafter.
Publications
Dietz A, Vannest J, Maloney T, Altaye M, Holland S, Szaflarski JP. The feasibility of improving discourse in people with aphasia through AAC: Clinical and functional MRI correlates. Aphasiology. 2018;32(6):693-719. doi: 10.1080/02687038.2018.1447641. Epub 2018 Mar 9.
PubMed 32999522
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of the Neurobiology of AAC-Induced Language Recovery in Post-Stroke Aphasia
- ClinicalTrials.gov ID
- NCT04081207
- Acronym / sponsor ID
- NAIL / 1R15DC017280-01
- Conditions
- Post-stroke Aphasia, Aphasia
- Keywords
- augmentative and alternative communication, aphasia, fMRI, DTI, neuroimaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Sep 2019 (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.
The currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. This study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. Further, this project will help us identify regions of the brain responsible for these changes.
Detailed description
In aphasia rehabilitation, usual care is focused on helping people recuperate as much of their pre-stroke language capacity as possible.Typically, usual care is a non-standardized therapy that is tailored to the specific needs of the person with aphasia.Once a person reaches a plateau in language recovery, AAC is implemented with a focus on circumventing, or compensating for the communication challenges associated with aphasia.
The ability of people with aphasia to (1) recover language function well-into the chronic phase of stroke recovery and (2) self-cue to promote word retrieval during anomic events offer the solution for how AAC could be employed as a dual-purpose tool to augment language recovery and compensate for deficits. This approach, however, this requires a shift in how AAC is implemented. With the goal of language recovery, treatment needs to focus on instructing people with aphasia how to use AAC as a mechanism for self-cueing, rather than as a tool to replace speaking. Based on our pilot data, we hypothesize that this novel method to AAC implementation will promote language recovery by coupling the canonical language and visual processing neural networks.
This work will also contribute to our ability to identify, a priori, who will respond to this particular AAC intervention and who will not, by combining neuroimaging with behavioral and clinical data. This has the potential to reduce the cost of healthcare for stroke recovery by implementing the most effective treatment possible. Importantly, when we identify non-responders, this will allow us to construct a profile and identify features of the AAC treatment that require adjustment to meet their unique needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participant cohorts: We will use a 2 (groups) X 4 (measurement time points) switching replications design[18] to examine the effects of AAC on aphasia severity and spoken language (AIM 1), elucidate the neurobiological mechanism of AAC-induced language recovery (AIM 2), and identify AAC treatment responder subgroups (Exploratory Aim). This design will allow Group 2 to serve as the control group; however, they will still receive AAC treatment; thus, allowing us to increase the total N who receives AAC treatment to 20 people.
| Arm | Type | Receives |
|---|---|---|
| AAC-LaRc | Experimental | Behavioral: AAC for Language Recovery (AAC-LaRc)all participants receive the experimental treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- at least 18 years old
- native speaker of american English
- compatible for 3 Tesla MRI
- Ischemic, left middle cerebral artery stroke
- at least 12 months post stroke
Key exclusion criteria (4 listed)
- fails to meet the above
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Report of pregnancy by women of childbearing age
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 |
|---|---|---|
| AAC for Language Recovery (AAC-LaRc)iPads will be programmed with a personalized communication application (app) and a structured 4-step intervention will be employed to instruct patients how to cue themselves during anomic events via pictures, text, or speak buttons. | Behavioural | AAC-LaRc |
Primary outcome
Western Aphasia Battery-Revised Aphasia Quotient
Time frame: 3 years
a diagnostic tool used to determine aphasia type and severity
Visual Regions of Interest Activation intensity
Time frame: 3 years
A functional magnetic resonance imaging (fMRI) measure to indicate change in brain involvement during resting state and language tasks.
Connectivity Indices
Time frame: 3 years
Connectivity indices reflect the temporal correlation between canonical language and visual regions of interest during language and resting state fMRI tasks.
8 secondary outcomes
Motor-Free Visual Perception Test-4
Time frame: 3 years
Discourse Analyses
Time frame: 3years
Communication analyses
Time frame: 3 years
Stroke and Aphasia Quality of Life-39 (SAQOL-39)
Time frame: 3 years
Communication Effectiveness Index (CETI)
Time frame: 3 years
Fractional Anisotropy (FA)
Time frame: 3 years
Mean Diffusivity (MD)
Time frame: 3 years
Language Lateralization Indices (LI)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Background: PubMed 32999522Dietz A, Vannest J, Maloney T, Altaye M, Holland S, Szaflarski JP. The feasibility of improving discourse in people with aphasia through AAC: Clinical and functional MRI correlates. Aphasiology. 2018;32(6):693-719. doi: 10.1080/02687038.2018.1447641. Epub 2018 Mar 9.
- Individual participant dataSharing planned: Yes. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects based on their private health information and language profiles. Further, it is possible to reconstruct faces from MRI data and the patients are easily identified through the testing and treatment videos; thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be shared at the time of publication, or shortly thereafter.
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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.
Aimee Dietz, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAC for Language Recovery (AAC-LaRc) in people with Post-stroke Aphasia and Aphasia, run by University of Cincinnati 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 12 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimee Dietz, PhD (513-558-8551, aimee.dietz@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Aphasia Battery-Revised Aphasia Quotient (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT04081207, which also lists 1 linked publication.
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 9 Sep 2019.