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| ID | Type | Description | Link |
|---|---|---|---|
| R56DC022256 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phono-Motor Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Aphasia Battery - Revised | The WAB - R is a standard measure of aphasia severity. It determines both the degree of aphasia and whether treatment has any impact on aspects of aphasia other than acquired dyslexia. | Baseline, following the first 60 hours of therapy, and following the final 60 hours of therapy. |
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Inclusion Criteria:
Exclusion Criteria:
All 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William W Graves, PhD | Contact | 973-353-3947 | william.graves@rutgers.edu | |
| Olga Boukrina, PhD | Contact | 973-324-3587 | OBoukrina@KesslerFoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| William W Graves, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32306 | United States |
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.
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 will be freely available by anyone using the OSF.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D004411 | Dyslexia, Acquired |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Semantic Feature Analysis | Behavioral | 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. |
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| Comprehensive Aphasia Test - Disability Quotient |
The CAT - DQ is a self-report measure of subjectively perceived degree of disability. |
| Baseline, following the first 60 hours of therapy, and following the final 60 hours of therapy. |
| Johns Hopkins University School of Medicine | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004410 | Dyslexia |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |