Neuroplasticity Biomarkers in Aphasia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Experimental word-learning task for aphasiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months, 6 months, 1 year post-stroke
2

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.

Time frame
At least 1 year post-stroke
3

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.

Time frame
At least 1 year post-stroke
4

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.

Time frame
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.

Time frame
1 year post-stroke

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator