Aphasia, AcquiredsentenceNCT06405594
Neurocognitive Mechanisms of Sentence Production Impairment in Aphasia
A study testing Language Condition in people with Aphasia, Acquired and Stroke, run by University of Maryland, College Park at 1 site in United States.
Trial summary
The proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Acquired, Stroke, Healthy Aging
- What is being tested?
- Language Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Persons with acquired aphasia are defined as those with a language impairment following left hemisphere brain injury (most likely a stroke).
- Neurotypical adults need to be either young (ages 18-30 years) or older (> 60 years)
- Native (or primary) speakers of English
Who cannot join
- Prior neurological or psychiatric diagnoses or developmental disabilities before the onset of aphasia
- do not speak English fluently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland
College Park, Maryland, 20742
Yasmeen Faroqi-Shah, PhD, 301-405-4229, yfshah@umd.edu
Robert Slevc, PhD, (301) 405-5835, slevc@umd.edu
About this study
The proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. By seeking to better understand post-stroke aphasia, this project lays the groundwork for development of new interventions, and aligns with NIDCD's priority areas 1 (understanding normal function), 2 (understanding diseases), and 3 (improving diagnosis, treatment, and prevention).
Read the detailed description
Post-stroke agrammatic aphasia (PSA-G) is characterized by a cluster of symptoms (fragmented sentences, errors in functional morphology, a dearth of verbs, and slow speech rate), yet extant theories and language interventions focus on individual symptoms. This single-symptom theoretical and intervention focus results in limited gains in functional communication. The long-term goal of this research is to improve the clinical effectiveness of interventions for PSA-G.
As a first step towards this goal, this project's objective is to advance the theoretical framework of PSA-G by addressing two critical gaps. The first gap is in the mechanistic understanding of how lexical, grammatical, motoric, and cognitive processes work together to enable fluent sentence production and how this breaks down in PSA-G. The second gap is in the understanding of neural mechanisms underlying how sentence production planning normally unfolds over time and what crucial spatiotemporal alterations give rise to PSA-G versus other variants of post-stroke aphasia with predominantly lexico-semantic deficits (PSA-LS). The central hypothesis is that agrammatic language production results from spatiotemporal alterations in the neural dynamics of morphosyntactic and phonomotor processes, causing a cumulative processing bottleneck at the point of articulatory planning. This Synergistic Processing Bottleneck Model of Agrammatism will be tested with two specific aims.
Specific Aim 1 will elucidate the relative contribution of syntactic and non-syntactic processes towards sentence production in aphasia by using speed metrics and a path modeling framework. The expected outcomes of this aim are an improved understanding of the extent to which delays in different linguistic processes underlying the agrammatic symptom cluster impair fluent sentence production in aphasia generally, and in PSA-G versus PSA-LS more specifically.
Specific Aim 2 will determine the neural mechanisms underlying sentence production across language deficit profiles. Magnetoencephalography (MEG) will be used to compare alterations in timecourse and functional connectivity of key perilesional and contralesional syntactic hubs across increasingly demanding morphosyntactic production tasks. The expected outcome of this aim is a spatiotemporally specified neural model of sentence production in neurotypical, PSA-G, and PSA-LS speakers.
The significance this research is that it will forward an empirically established multidimensional model of sentence production, which will lay the foundation for developing more targeted and effective language interventions for agrammatic aphasia. It will also contribute to a better understanding of agrammatism in neurodegenerative aphasias. The innovative aspects of this project include: a novel multidimensional theoretical framework that incorporates non-syntactic dimensions of phonomotor planning, processing capacity and speed, and neurophysiological dynamics; direct comparisons between PSA-G and PSA-LS groups; and MEG analysis of spoken language with simultaneous electromyographic measurement.
- Conditions
- Aphasia, Acquired, Stroke, Healthy Aging
- Being tested
- Language Condition
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language ConditionBehavioural
The intervention involves asking participants to speak and understand words and sentences with different linguistic manipulations such as morphological, semantic, phonological priming, predictability of the subject and object nouns associated with verbs, naming of verbs and nouns, production of sentences with past, future or present tense. Accuracy, response times and brain activity are the outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| Language condition | Experimental | All participants will receive this arm. In this arm, the intervention involves asking participants to speak and understand words and sentences with different linguistic manipulations such as morphological, semantic, phonological priming, predictability of the subject and object nouns associated with verbs, naming of verbs and nouns, production of sentences with past, future or present tense. Accuracy, response times and brain activity are the outcome measures. Receives: Behavioral: Language Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Response accuracy for each experimental condition will be measured
Measured: through the completion of the study, an average of 1 year
Response time
Response times for each experimental condition will be measured
Measured: through the completion of the study, an average of 1 year
Brain activity
Patterns of brain activity (using magnetoencephalography and MRI) will be measured for each experimental condition
Measured: through the completion of the study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Aug 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same intervention (language condition) and a single arm (language condition)
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Yasmeen Faroqi Shah, University of Maryland, College Park
- Investigators
- Yasmeen Faroqi-Shah, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405594
- Sponsor's protocol ID
- 2044118-1
- Acronym
- sentence
- Status last verified
- Aug 2024
- First submitted
- 1 May 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Mechanisms of Sentence Production Impairment in Aphasia
- ClinicalTrials.gov ID
- NCT06405594
- Acronym / sponsor ID
- sentence / 2044118-1
- Conditions
- Aphasia, Acquired, Stroke, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 8 May 2024 (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 proposed research is relevant to public health because stroke is a leading cause of long-term disability among older adults and communication impairments resulting from stroke have a significant negative impact on quality of life. By seeking to better understand post-stroke aphasia, this project lays the groundwork for development of new interventions, and aligns with NIDCD's priority areas 1 (understanding normal function), 2 (understanding diseases), and 3 (improving diagnosis, treatment, and prevention).
Detailed description
Post-stroke agrammatic aphasia (PSA-G) is characterized by a cluster of symptoms (fragmented sentences, errors in functional morphology, a dearth of verbs, and slow speech rate), yet extant theories and language interventions focus on individual symptoms. This single-symptom theoretical and intervention focus results in limited gains in functional communication. The long-term goal of this research is to improve the clinical effectiveness of interventions for PSA-G.
As a first step towards this goal, this project's objective is to advance the theoretical framework of PSA-G by addressing two critical gaps. The first gap is in the mechanistic understanding of how lexical, grammatical, motoric, and cognitive processes work together to enable fluent sentence production and how this breaks down in PSA-G. The second gap is in the understanding of neural mechanisms underlying how sentence production planning normally unfolds over time and what crucial spatiotemporal alterations give rise to PSA-G versus other variants of post-stroke aphasia with predominantly lexico-semantic deficits (PSA-LS). The central hypothesis is that agrammatic language production results from spatiotemporal alterations in the neural dynamics of morphosyntactic and phonomotor processes, causing a cumulative processing bottleneck at the point of articulatory planning. This Synergistic Processing Bottleneck Model of Agrammatism will be tested with two specific aims.
Specific Aim 1 will elucidate the relative contribution of syntactic and non-syntactic processes towards sentence production in aphasia by using speed metrics and a path modeling framework. The expected outcomes of this aim are an improved understanding of the extent to which delays in different linguistic processes underlying the agrammatic symptom cluster impair fluent sentence production in aphasia generally, and in PSA-G versus PSA-LS more specifically.
Specific Aim 2 will determine the neural mechanisms underlying sentence production across language deficit profiles. Magnetoencephalography (MEG) will be used to compare alterations in timecourse and functional connectivity of key perilesional and contralesional syntactic hubs across increasingly demanding morphosyntactic production tasks. The expected outcome of this aim is a spatiotemporally specified neural model of sentence production in neurotypical, PSA-G, and PSA-LS speakers.
The significance this research is that it will forward an empirically established multidimensional model of sentence production, which will lay the foundation for developing more targeted and effective language interventions for agrammatic aphasia. It will also contribute to a better understanding of agrammatism in neurodegenerative aphasias. The innovative aspects of this project include: a novel multidimensional theoretical framework that incorporates non-syntactic dimensions of phonomotor planning, processing capacity and speed, and neurophysiological dynamics; direct comparisons between PSA-G and PSA-LS groups; and MEG analysis of spoken language with simultaneous electromyographic measurement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same intervention (language condition) and a single arm (language condition)
| Arm | Type | Receives |
|---|---|---|
| Language condition | Experimental | Behavioral: Language ConditionAll participants will receive this arm. In this arm, the intervention involves asking participants to speak and understand words and sentences with different linguistic manipulations such as morphological, semantic, phonological priming, predictability of the subject and object nouns associated with verbs, naming of verbs and nouns, production of sentences with past, future or present tense. Accuracy, response times and brain activity are the outcome measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Persons with acquired aphasia are defined as those with a language impairment following left hemisphere brain injury (most likely a stroke).
- Neurotypical adults need to be either young (ages 18-30 years) or older (> 60 years)
- Native (or primary) speakers of English
Key exclusion criteria (2 listed)
- Prior neurological or psychiatric diagnoses or developmental disabilities before the onset of aphasia
- do not speak English fluently
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 |
|---|---|---|
| Language ConditionThe intervention involves asking participants to speak and understand words and sentences with different linguistic manipulations such as morphological, semantic, phonological priming, predictability of the subject and object nouns associated with verbs, naming of verbs and nouns, production of sentences with past, future or present tense. Accuracy, response times and brain activity are the outcome measures. | Behavioural | Language condition |
Primary outcome
Accuracy
Time frame: through the completion of the study, an average of 1 year
Response accuracy for each experimental condition will be measured
Response time
Time frame: through the completion of the study, an average of 1 year
Response times for each experimental condition will be measured
Brain activity
Time frame: through the completion of the study, an average of 1 year
Patterns of brain activity (using magnetoencephalography and MRI) will be measured for each experimental condition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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.
Yasmeen Faroqi-Shah, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language Condition in people with Aphasia, Acquired and Stroke, run by University of Maryland, College Park 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 4 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: looking for participants now, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen Faroqi-Shah, PhD (3014054229, yfshah@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: through the completion of the study, an average of 1 year). 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?
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 3 Sep 2024.