Dyslexia Clinical Trial
Official title:
Evaluating the Impact of Non-Invasive Brain Stimulation on Learning and Consolidation of Phonologically Similar Novel Spoken Words
The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 24 Years |
Eligibility | Inclusion Criteria: - Native English speaker (who is not fluent in any other language and does not identify as bilingual) - Normal or corrected to normal vision Exclusion Criteria: - Diagnosed with Autism Spectrum Disorder - Hearing deficits (>25 decibels at 500+ Hz), visual deficits (>20/40), serious emotional problems (e.g., severe, uncontrolled depression) and certain neurological conditions (e.g., uncontrolled seizure disorders) - Individuals with certain metals in their bodies or with certain health conditions. If an individual has braces on their teeth, a cardiac pacemaker; hearing aid; other metal in their body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects - Individuals taking certain medications that lower seizure threshold - Individuals with TMS Screening and Contraindication Forms which do not pass TMS Tech review - Individuals with MRI Screening and Contraindication Forms which do not pass MRI Tech review |
Country | Name | City | State |
---|---|---|---|
United States | Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI) | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Georgia State University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. — View Citation
Olson R, Forsberg H, Wise B, Rack J. Measurement of word recognition, orthographic, and phonological skills. In: Frames of Reference for the Assessment of Learning Disabilities: New Views on Measurement Issues. Paul H. Brookes Publishing Co.; 1994:243-277.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Novel Word Learning Task | The spoken word learning task, completed post-cTBS, will consist of a two-alternative forced choice paradigm in which participants will be presented with two pictures of unusual objects, and will be asked to indicate via button press which picture matches a spoken label. Initial trials require a pure guess, with feedback provided on each trial, and continued until a correct answer is given. Across six learning blocks (24 trials each), participants will learn a set of eight pseudowords total. Twenty-four hours following the initial learning task, participants will be asked to complete two additional learning blocks which will be used to assess retention accuracy. Over the course of the experiment, participants will learn two different sets of items, counter-balanced across participants and groups. | 5-mins post stimulation; 24hrs post stimulation | |
Primary | Pseudoword Discrimination Task | The visual pseudoword discrimination task is a computerized forced-choice, reaction time assessment of phonological processing. It measures the participants' ability to phonetically decode a string of letters. This task is simple with high accuracy and has proven highly sensitive to individual differences in phonological decoding skills. Participants are asked to judge via button press whether a visually presented letter string can be pronounced like a 'real word' or not. | Immediately following cTBS | |
Secondary | MRI Scan | Pre-rTMS MRI scans will consist of anatomical and functional sequences consistent with well-established protocols in the field designed to assess baseline properties and functioning of the reading and language network. The functional MRI (fMRI) Picture Identification task is simple with high accuracy and has proven highly sensitive to individual differences in reading skills. Participants are asked to indicate via button press whether a target stimulus (written or spoken word) matches a picture cue. The fMRI Fast Localizer task rapidly presents sets of four words that vary based on orthographic, phonological, or semantic properties. Anatomical scans are necessary for localizing brain regions targeted for cTBS. | baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00716274 -
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
|
Phase 4 | |
Recruiting |
NCT03695068 -
Efficacy of a Two-Year Intensive Reading Intervention for Middle School English Learners With Reading Difficulties
|
N/A | |
Completed |
NCT04277351 -
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
|
N/A | |
Recruiting |
NCT05996497 -
Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
|
N/A | |
Not yet recruiting |
NCT04989088 -
Neurofeedback Training for Dyslexia
|
N/A | |
Completed |
NCT02429739 -
Working Memory Training for Children With Dyslexia
|
N/A | |
Completed |
NCT05154721 -
Rhythm Training of a Serious Game on the Reading Skills of Children w/ a Specific Learning Disorder Impacting Reading
|
N/A | |
Completed |
NCT01930500 -
The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults
|
N/A | |
Unknown status |
NCT00818428 -
Randomized Clinical Trial of Phonological Interventions
|
Phase 2/Phase 3 | |
Recruiting |
NCT05514457 -
Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
|
N/A | |
Completed |
NCT04642859 -
Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt
|
N/A | |
Completed |
NCT01012778 -
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06127550 -
taVNS for Letter Learning in Dyslexia
|
N/A | |
Completed |
NCT04244578 -
Transcranial Direct Current Stimulation in the Treatment of Dyslexia.
|
N/A | |
Recruiting |
NCT05636813 -
Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia
|
N/A | |
Completed |
NCT02872870 -
Developmental Language Difficulties: Behavioural and Electrophysiological Studies
|
N/A | |
Completed |
NCT00607919 -
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
|
Phase 4 | |
Completed |
NCT00245804 -
Developmental Dyslexia and Functional Maturation of Auditory Cortex
|
N/A | |
Completed |
NCT02345876 -
Maturation of Auditory Processing in Children With Dyslexia Compared to Average-reading Children
|
||
Completed |
NCT04708899 -
Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD
|
N/A |