NCT07209488

Brief Summary

This study is a low-risk, early phase 1, multicenter trial to test the use of a computational (neural network) cognitive model of reading to simulate acquired dyslexia and its treatment. The aim is to determine whether there is an advantage to receiving the treatment the model predicts to be advantageous compared to the alternative treatment. All participants will receive two full rounds of treatment. A round of treatment will consist of either phonomotor treatment (PMT) or semantic feature analysis (SFA) for 60 hours, distributed over 5 days a week for 2 hours a day.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
4mo left

Started Dec 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Dec 2025Sep 2026

First Submitted

Initial submission to the registry

October 2, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

October 2, 2025

Last Update Submit

May 5, 2026

Conditions

Keywords

readingcomputational modeltreatmenttherapy

Outcome Measures

Primary Outcomes (2)

  • Woodcock Reading Mastery Test - III

    The WRMT-III is a standardized measure of reading skills.

    Baseline, following the first 60 hours of therapy, and following the final 60 hours of therapy.

  • Test words and pseudowords

    Change in accuracy of reading 120 test words and 80 pseudowords

    Baseline, following the first 60 hours of therapy, and following the final 60 hours of therapy.

Secondary Outcomes (2)

  • Western Aphasia Battery - Revised

    Baseline, following the first 60 hours of therapy, and following the final 60 hours of therapy.

  • Comprehensive Aphasia Test - Disability Quotient

    Baseline, following the first 60 hours of therapy, and following the final 60 hours of therapy.

Study Arms (2)

Model-matched

EXPERIMENTAL

This group will receive the therapy, either phonological or semantics-based, that matches the computational model prediction for the source of their reading impairment. They will receive this for the first 60 total hours of therapy, and for the second 60 hours of therapy.

Behavioral: Phono-Motor TherapyBehavioral: Semantic Feature Analysis

Model-non-matched

ACTIVE COMPARATOR

This group will receive the therapy, either phonological or semantics-based, that does not match the computational model prediction for the source of their reading impairment. They will receive this for the first 60 total hours of therapy. For the second 60 hours, they will receive the other therapy.

Behavioral: Phono-Motor TherapyBehavioral: Semantic Feature Analysis

Interventions

Orthographic stimuli (letters) are introduced from the beginning as each phoneme is being trained. This maintains the focus on phonology, while emphasizing its relevance to reading. PMT consists of an initial phase focused on training of individual phonemes and phoneme sequences in spoken language, followed by written language tasks. English phonemes are first trained in isolation, followed by phoneme sequences in words and pseudowords. They are trained multi-modally through emphasis on auditory, motor, tactile-kinesthetic, visual, and orthographic representations for each consonant and vowel. When sequences are introduced, focus on phonology is maintained by training on pseudowords first before real words are introduced. Participants work on identifying, repeating, parsing, blending, and manipulating phonemes that make up the pseudoword and word stimuli. To maintain focus on phonology, pictures and definitions of the stimuli are never shown or discussed.

Also known as: PMT
Model-matchedModel-non-matched

SFA activates semantic features of the target word to help retrieve the spoken form of the word. To target reading, a modified SFA is used with written words rather than pictures as the primary materials. Pictures are instead included for each word as a semantic feature. Stimuli will consist of 80 highly imageable nouns with a range of word frequencies. During treatment the therapist will present a written noun and ask the participant a series of questions about the features of that noun. For example, if the presented noun is "juice", the therapist would have the participant select the corresponding picture from an array of pictures. The therapist then would ask, "what do you do with it?" (eliciting a feature from the "function" category) and "where do you store it in your home?" (eliciting a feature from the "context" category). This is done for a total of 6 categories of semantic features. The process is repeated until the participant reads the noun correctly three times in a row.

Also known as: SFA
Model-matchedModel-non-matched

Eligibility Criteria

Age18 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll participants in the study population will be given equal consideration for inclusion, and no preference will be given on the basis of gender. This measure is based on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English as a first language pre-stroke by self report.
  • Normal or corrected-to-normal vision.
  • Normal or aided hearing.
  • Left hemisphere ischemic or hemorrhagic stroke (as verified by a structural brain scan).
  • Impaired reading as confirmed by significant impairment in the Basic Skills cluster of the Woodcock Reading Mastery Test - III.

You may not qualify if:

  • Diagnosed pre-stroke neurological disease affecting the brain other than left hemisphere stroke.
  • Severe apraxia of speech (determined by consensus judgment among speech-language pathologists).
  • History of learning disabilities such as developmental dyslexia or current self-reported major psychiatric disorders.
  • Inability to undergo, or provide a copy of, a post-stroke brain imaging scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

StrokeDyslexia, Acquired

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDyslexiaLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersNeurodevelopmental Disorders

Study Officials

  • William W Graves, PhD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study model is a partial crossover design in that participants receiving model-matched therapy will continue with the same therapy in the 2nd half of the study, while those receiving the non-model-matched therapy will be switched in the 2nd half to the other therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2025

First Posted

October 7, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Pursuant to the rules of the Institutional Review Board of Rutgers, The State University of New Jersey, only data that can be fully de-identified will be shared. All data collected using non-proprietary (non-copyrighted) instruments are expected to be de-identifiable and therefore will be shared in de-identified form. These include: structural brain images (de-faced), results of the test for hemi-spatial neglect, the experimental list of 120 words and 80 pseudowords for reading aloud, and results of touch-screen choice tasks for testing phonological, semantic, and orthographic knowledge.

Shared Documents
STUDY PROTOCOL
Time Frame
We will make the behavioral and brain MRI data available through the Open Science Framework (OSF) repository as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. We will also make the data available for as long as we anticipate it being useful for the larger research community, institutions, and/or the broader public.
Access Criteria
Access will be freely available by anyone using the OSF.

Locations