An interventional study of Active cTBS and Sham in Dyslexia, Dyslexia, Developmental and Learning; Developmental Disorder, Reading, sponsored by Georgia State University. Completed at 1 site in United States. Open to participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Georgia State University · Not applicable, Interventional, and Basic science
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.
The proposed study is designed to assess the contribution of the dorsal stream of the language network (i.e., left supramarginal gyrus, or SMG) to different aspects of novel word learning in two groups of participants (16-24 years of age): 20 typically developing older youth (OYTD; tested in Aim 1) and 20 older youth with reading difficulties (OYRD; tested in Aim 2). The investigators will use inhibitory continuous theta burst stimulation (cTBS), a well-established repetitive TMS (rTMS) protocol that reduces cortical excitability in a targeted brain region for up to 60 minutes. Participants will complete a baseline magnetic resonance imaging (MRI) session in Week 1, followed by cTBS or sham stimulation to the left SMG, with order of administration counterbalanced across participants. Immediately following cTBS (or sham), participants will complete a visual pseudoword phonological discrimination task and a spoken word learning task. The following day (i.e., 24 hours later), retention of items learned will be measured. In Week 2, cTBS (or sham) will be administered to the left SMG (whichever stimulation was not administered in Week 1) and then the pseudoword discrimination and word learning tasks will be administered using a different set of novel words from those presented in Week 1. Twenty-four hours later, the retention of this second set of items will be measured.
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's enrollment of 42 is below the median of 71 across 106 interventional studies indexed under Dyslexia.
Browse Dyslexia studies →Georgia State University is the lead sponsor of 56 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Active cTBS will be administered to the left supramarginal gyrus
Other: Active cTBS
Sham stimulation will be administered to the left supramarginal gyrus
Other: Sham
Active stimulation
Control stimulation
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.
Time frame: 5-mins post stimulation; 24hrs post stimulation
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.
Time frame: Immediately following cTBS
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.
Time frame: baseline
Plan to share: Yes — The Open Science Framework (OSF) will be engaged to facilitate research integration in multiple aspects including collaboration among personnel, study design, data collection and analyses, and publication access. In addition, neuroimaging and behavioral data will be shared by depositing it in the Collaborative Informatics and Neuroimaging Suite (COINS), a platform hosted by Georgia State University/Georgia Institute of Technology/Emory University Center for Translational Research in Neuroimaging and Data Science (TReNDS). TReNDS allows for safe and secure data sharing with external users without granting access to protected health information. For preprints, platforms such as PsyArXiv and OSF Preprints will be used based on appropriate content area. All personnel will commit to use OSF to publicly share evaluation and research components.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Timely submission of raw data to repositories will provide an additional layer of safety. Neuroimaging data will be uploaded to COINS in real time. Cleaned behavioral datasets will be uploaded to OSF biannually. Metadata, code, small datasets and links to large datasets used in publications will be archived as supplements or on OSF. Publication specific data will be deposited to the OpenNeuro platform upon publication. All shareable data from this project will be made publicly available no later than the end of the project period, and any data associated with a publication will be made available at the time of publication. The latest point at which data will be provided to the archive is when articles using that data are accepted for publication, or at the conclusion of the project (whichever comes first).
Access criteria: Any physical data for this project will be stored within locked filing cabinets for print copies and digital files will be encrypted and stored on password-protected secure servers separately from any participant code keys. Archived data will be stored on a secure server at Georgia State University when primary planned analyses of the data have been completed. The server will be backed up regularly using a tape backup system. The partition where data will sit on the server will not be accessible to anyone outside of the team. Audit trails are maintained for each file to document changes and deletions, and older versions of files are retrievable in the event of unintentional modification.
Ran from Jan 2024 to primary completion in Nov 2025, 22 months.
Of 62 non-industry interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's 22 months is close to that.
Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 9 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Georgia State University