Neuroplasticity Biomarkers in Aphasia

NCT06471127 | Recruiting

• 5 other identifiers: 2023-11011K23DC021744A481800L&S/COMMUN SCI & DISORDERSProtocol Version 9/26/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aphasia; Language; Stroke

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  At least 1 year post-stroke

Secondary Outcomes (1)

• Aphasia Communication Outcome Measure (ACOM) Score

  1 year post-stroke

Study Arms (1)

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.

Behavioral: Pseudoword learning paradigm task

Interventions

Pseudoword learning paradigm task BEHAVIORAL

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.

Experimental word-learning task for aphasia

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Aphasia; Language; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Haley Dresang, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Dresang, PhD

CONTACT

(608) 890-0628; hdresang@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)