AphasiaNCT06471127
Neuroplasticity Biomarkers in Aphasia
A study testing Pseudoword learning paradigm task in people with Aphasia and Language, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Patients with stroke frequently suffer from aphasia, a disorder of expressive and/or receptive language, that can lead to serious health consequences, including social isolation, depression, reduced quality of life, and increased caregiver burden. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- What is being tested?
- Pseudoword learning paradigm task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 31 May 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 40-90
- Right-handed (prior to stroke)
- Proficient English speakers
- History of a single ischemic stroke in the middle cerebral artery territory that is lateralized to the left or right (Aim 1) cerebral hemisphere.
- Presence of aphasia (Aims 2-3)
- Capacity to understand the nature of the study and provide informed consent
- Acute or subacute stroke at the time of Aim 1 enrollment; Stroke #12 months old (chronic) at the time of Aims 2-3 enrollment
- Medically stable
Who cannot join
- History of significant medical or neurological disorder (other than stroke)
- History of significant or poorly controlled psychiatric disorders
- Current abuse of alcohol or drugs, prescription or otherwise
- Clinically significant and uncorrected vision or hearing loss
- Anything other than standard of care stroke treatment such as Plavix, aspirin (81-300 mg daily), beta-blockers, diabetes medications or choles- terol-lowering agents, thrombolytics (e.g., tPA), anticoagulation agents such as Heparin, Warfarin/Coumadin
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
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Genetic and MRI Biomarkers of Neuroplasticity Predict Aphasia Recovery and Phenotypes
Patients with stroke frequently suffer from aphasia, a disorder of expressive and/or receptive language, that can lead to serious health consequences, including social isolation, depression, reduced quality of life, and increased caregiver burden. Aphasia recovery varies greatly between individuals, and likely relies upon the capacity for neuroplasticity, both at a systems level of reorganized brain networks and a molecular level of neuronal repair and plasticity. The proposed work will evaluate genetic and neural network biological markers of neuroplasticity associated with variability in aphasia, with a future goal to improve prognostics and identify therapeutic targets to reduce the long-term burdens of aphasia.
Read the detailed description
Aphasia is an acquired neurologic language disorder that is among the most challenging long-term disabilities for stroke survivors, often leading to social isolation and reduced quality of life. Recovery from aphasia relies on plasticity in residual brain networks. However, neuroplasticity varies substantially across individuals, making the presence, severity, and phenotype of language impairments challenging to predict. A vital step toward post-stroke precision medicine is identifying neuroplasticity-related biological markers that can improve prognostic models and targeted neurorehabilitation therapies for people with aphasia. The proposed research will test the central hypothesis that individual differences in neuroplasticity, measured through genetic polymorphisms and longitudinal neuroimaging connectivity biomarkers, will account for significant variance in post-stroke aphasia recovery. This 5-year project will include three specific aims. Aim 1 is to index spontaneous recovery by determining relationships between genetic biomarkers of plasticity, longitudinal neural network connectivity, and changes in language during sub-acute to chronic stroke recovery. Aim 2 is to identify genetic and MRI biomarkers predictive of chronic post-stroke aphasia severity and phenotypes. Aim 3 is to characterize genetic and MRI biomarkers associated with verbal learning variability in chronic aphasia. These data will support the development of a larger, multi-site R01 study to examine interactions between multiple biomarkers of neuroplasticity that inform longitudinal aphasia prognostics and treatment efficacy.
- Being tested
- Pseudoword learning paradigm task
- Medical subject headings
- Aphasia, Language, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoword learning paradigm taskBehavioural
Pseudoword learning is an experimental learning task by which participants view two novel objects (a target and a foil) and simultaneously hear an audio recording of the pseudoword name of one of the two objects. Participants must choose (via mouse click) which object corresponds to the word presented, immediately after which feedback is provided.
| Study group | Role | What they receive |
|---|---|---|
| Experimental word-learning task for aphasia | Experimental | The word learning task includes 210 trials across 7 learning blocks (30 trials/block). Each trial features two novel objects (target and foil) on the screen, with an audio recording naming one object. Subjects must quickly and accurately identify the named object. Correct responses are rewarded with a happy face, and incorrect ones with a sad face. The target object's position is counter-balanced, and trial order is randomized for each subject. Short pauses occur every 60 trials to reduce fatigue. After 7 learning blocks, feedback is discontinued, and an immediate test block assesses word-referent recognition. A week later, a second test block, with the same instructions, measures retained learning. Each test block consists of 30 randomized trials without feedback. Receives: Behavioral: Pseudoword learning paradigm task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aphasia presence/severity
The primary outcome measure for Aim 1 will be overall aphasia severity. Severity across language domains will be measured by Western Aphasia Battery-Revised Aphasia Quotient (AQ). AQ scores range from 0-100 and rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76+ is mild.
Measured: 3 months, 6 months, 1 year post-stroke
Semantic processing
A primary outcome measure for Aim 2 will be semantic versus phonological processing ability. Semantic processing will be measured by the three pictures version of the Pyramids and Palm Trees Test (PPT) and Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) 51: Word Semantic Association, and semantic weights will be calculated from Philadelphia Naming Test (PNT).
PPT ranges from 0-52, with higher scores indicating a better ability to retrieve item names from semantic memory.
PALPA 51 ranges from 0 to 40, with each correct semantic association earning one point.
PNT semantic weights refer to the measure of the semantic relatedness of the words used in the test.
Measured: At least 1 year post-stroke
Phonological processing
A primary outcome measure for Aim 2 will be semantic versus phonological processing ability. Phonological processing will be measured by PALPA 1: Same-Different Discrimination Using Nonword Minimal Pairs as a measure of input phonology and phonological weights will be calculated from Philadelphia Naming Test (PNT).
PALPA 1 range is 0 to 40, with higher scores indicating greater accuracy. PNT phonological weights refer to the measure of the phonologic relatedness of the words used in the test.
Measured: At least 1 year post-stroke
Noun processing
A primary outcome measure for Aim 2 will be noun versus verb processing ability. Noun processing will be measured by Object and Action Naming Battery (OANB) to assess production and Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) 47 to assess comprehension.
PALPA 47 range is from 0 to 40, with higher scores indicating greater accuracy. OANB object naming range is 0 to 162, with higher scores indicating greater accuracy.
Measured: At least 1 year post-stroke
Verb processing
A primary outcome measure for Aim 2 will be noun versus verb processing ability. Verb processing will be measured by Object and Action Naming to assess production and Northwestern Assessment of Verbs and Sentences (NAVS) Verb Comprehension Test.
NAVS Verb Comprehension range is 0-22, with higher scores indicating greater accuracy.
OANB action naming range is 0 to 100, with higher scores indicating greater accuracy.
Measured: At least 1 year post-stroke
Pseudoword learning
A primary outcome measure for Aim 3 will be pseudoword learning, with scores for immediate recognition and delayed recognition ability. This experimental paradigm has been implemented in patients with aphasia by Penaloza and colleagues from the Ancient Farming Equipment Paradigm.
This assessment is measured in proportion of correction responses, range 0-100%, with higher scores indicating greater accuracy.
Measured: At least 1 year post-stroke
Verbal learning
A primary outcome measure for Aim 3 will be verbal learning, which will be measured by the standardized assessment of Hopkins Verbal Learning Test. Immediate recall is range 0-36 and delayed recall is range 0-12. Higher scores indicate more words recalled. Recognition is range 0-12, with higher scores indicating better ability to correctly identify previously learned information among distractors.
Measured: At least 1 year post-stroke
Secondary outcomes (1)
Aphasia Communication Outcome Measure (ACOM) Score
The ACOM is a patient-reported measure of communicative effectiveness for persons with aphasia. A final T-score will be scaled such that the mean is 50 and the standard deviation is 10. Higher scores indicate better communicative functioning.
Measured: 1 year post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start17 Mar 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
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 University of Wisconsin, MadisonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Translational. This protocol 1) tests neural mechanisms of connectivity and reorganization that support post-stroke language recovery and 2) determines biomarkers predictive of language impairments to improve prognostics for persons with aphasia.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Haley Dresang, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471127
- Sponsor's protocol ID
- 2023-1101
- Other IDs
- 1K23DC021744, A481800, L&S/COMMUN SCI & DISORDERS, Protocol Version 6/18/2026
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and MRI Biomarkers of Neuroplasticity Predict Aphasia Recovery and Phenotypes
- ClinicalTrials.gov ID
- NCT06471127
- Acronym / sponsor ID
- 2023-1101
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 24 Jun 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.
Patients with stroke frequently suffer from aphasia, a disorder of expressive and/or receptive language, that can lead to serious health consequences, including social isolation, depression, reduced quality of life, and increased caregiver burden. Aphasia recovery varies greatly between individuals, and likely relies upon the capacity for neuroplasticity, both at a systems level of reorganized brain networks and a molecular level of neuronal repair and plasticity. The proposed work will evaluate genetic and neural network biological markers of neuroplasticity associated with variability in aphasia, with a future goal to improve prognostics and identify therapeutic targets to reduce the long-term burdens of aphasia.
Detailed description
Aphasia is an acquired neurologic language disorder that is among the most challenging long-term disabilities for stroke survivors, often leading to social isolation and reduced quality of life. Recovery from aphasia relies on plasticity in residual brain networks. However, neuroplasticity varies substantially across individuals, making the presence, severity, and phenotype of language impairments challenging to predict. A vital step toward post-stroke precision medicine is identifying neuroplasticity-related biological markers that can improve prognostic models and targeted neurorehabilitation therapies for people with aphasia. The proposed research will test the central hypothesis that individual differences in neuroplasticity, measured through genetic polymorphisms and longitudinal neuroimaging connectivity biomarkers, will account for significant variance in post-stroke aphasia recovery. This 5-year project will include three specific aims. Aim 1 is to index spontaneous recovery by determining relationships between genetic biomarkers of plasticity, longitudinal neural network connectivity, and changes in language during sub-acute to chronic stroke recovery. Aim 2 is to identify genetic and MRI biomarkers predictive of chronic post-stroke aphasia severity and phenotypes. Aim 3 is to characterize genetic and MRI biomarkers associated with verbal learning variability in chronic aphasia. These data will support the development of a larger, multi-site R01 study to examine interactions between multiple biomarkers of neuroplasticity that inform longitudinal aphasia prognostics and treatment efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Translational. This protocol 1) tests neural mechanisms of connectivity and reorganization that support post-stroke language recovery and 2) determines biomarkers predictive of language impairments to improve prognostics for persons with aphasia.
| Arm | Type | Receives |
|---|---|---|
| Experimental word-learning task for aphasia | Experimental | Behavioral: Pseudoword learning paradigm taskThe word learning task includes 210 trials across 7 learning blocks (30 trials/block). Each trial features two novel objects (target and foil) on the screen, with an audio recording naming one object. Subjects must quickly and accurately identify the named object. Correct responses are rewarded with a happy face, and incorrect ones with a sad face. The target object's position is counter-balanced, and trial order is randomized for each subject. Short pauses occur every 60 trials to reduce fatigue. After 7 learning blocks, feedback is discontinued, and an immediate test block assesses word-referent recognition. A week later, a second test block, with the same instructions, measures retained learning. Each test block consists of 30 randomized trials without feedback. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 40-90
- Right-handed (prior to stroke)
- Proficient English speakers
- History of a single ischemic stroke in the middle cerebral artery territory that is lateralized to the left or right (Aim 1) cerebral hemisphere.
- Presence of aphasia (Aims 2-3)
Key exclusion criteria (5 listed)
- History of significant medical or neurological disorder (other than stroke)
- History of significant or poorly controlled psychiatric disorders
- Current abuse of alcohol or drugs, prescription or otherwise
- Clinically significant and uncorrected vision or hearing loss
- Anything other than standard of care stroke treatment such as Plavix, aspirin (81-300 mg daily), beta-blockers, diabetes medications or choles- terol-lowering agents, thrombolytics (e.g., tPA), anticoagulation agents such as Heparin, Warfarin/Coumadin
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 |
|---|---|---|
| Pseudoword learning paradigm taskPseudoword learning is an experimental learning task by which participants view two novel objects (a target and a foil) and simultaneously hear an audio recording of the pseudoword name of one of the two objects. Participants must choose (via mouse click) which object corresponds to the word presented, immediately after which feedback is provided. | Behavioural | Experimental word-learning task for aphasia |
Primary outcome
Aphasia presence/severity
Time frame: 3 months, 6 months, 1 year post-stroke
The primary outcome measure for Aim 1 will be overall aphasia severity. Severity across language domains will be measured by Western Aphasia Battery-Revised Aphasia Quotient (AQ). AQ scores range from 0-100 and rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76+ is mild.
Semantic processing
Time frame: At least 1 year post-stroke
A primary outcome measure for Aim 2 will be semantic versus phonological processing ability. Semantic processing will be measured by the three pictures version of the Pyramids and Palm Trees Test (PPT) and Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) 51: Word Semantic Association, and semantic weights will be calculated from Philadelphia Naming Test (PNT). PPT ranges from 0-52, with higher scores indicating a better ability to retrieve item names from semantic memory. PALPA 51 ranges from 0 to 40, with each correct semantic association earning one point. PNT semantic weights refer to the measure of the semantic relatedness of the words used in the test.
Phonological processing
Time frame: At least 1 year post-stroke
A primary outcome measure for Aim 2 will be semantic versus phonological processing ability. Phonological processing will be measured by PALPA 1: Same-Different Discrimination Using Nonword Minimal Pairs as a measure of input phonology and phonological weights will be calculated from Philadelphia Naming Test (PNT). PALPA 1 range is 0 to 40, with higher scores indicating greater accuracy. PNT phonological weights refer to the measure of the phonologic relatedness of the words used in the test.
Noun processing
Time frame: At least 1 year post-stroke
A primary outcome measure for Aim 2 will be noun versus verb processing ability. Noun processing will be measured by Object and Action Naming Battery (OANB) to assess production and Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) 47 to assess comprehension. PALPA 47 range is from 0 to 40, with higher scores indicating greater accuracy. OANB object naming range is 0 to 162, with higher scores indicating greater accuracy.
Verb processing
Time frame: At least 1 year post-stroke
A primary outcome measure for Aim 2 will be noun versus verb processing ability. Verb processing will be measured by Object and Action Naming to assess production and Northwestern Assessment of Verbs and Sentences (NAVS) Verb Comprehension Test. NAVS Verb Comprehension range is 0-22, with higher scores indicating greater accuracy. OANB action naming range is 0 to 100, with higher scores indicating greater accuracy.
Pseudoword learning
Time frame: At least 1 year post-stroke
A primary outcome measure for Aim 3 will be pseudoword learning, with scores for immediate recognition and delayed recognition ability. This experimental paradigm has been implemented in patients with aphasia by Penaloza and colleagues from the Ancient Farming Equipment Paradigm. This assessment is measured in proportion of correction responses, range 0-100%, with higher scores indicating greater accuracy.
Verbal learning
Time frame: At least 1 year post-stroke
A primary outcome measure for Aim 3 will be verbal learning, which will be measured by the standardized assessment of Hopkins Verbal Learning Test. Immediate recall is range 0-36 and delayed recall is range 0-12. Higher scores indicate more words recalled. Recognition is range 0-12, with higher scores indicating better ability to correctly identify previously learned information among distractors.
1 secondary outcome
Aphasia Communication Outcome Measure (ACOM) Score
Time frame: 1 year post-stroke
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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
Aphasia, Stroke
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.
Haley Dresang, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pseudoword learning paradigm task in people with Aphasia and Language, run by University of Wisconsin, Madison 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 8 inclusion and 5 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 7 Jul 2026. 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 Haley Dresang, PhD ((608) 890-0628, hdresang@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aphasia presence/severity (time frame: 3 months, 6 months, 1 year post-stroke). The study lists 7 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 7 Jul 2026.