DyslexiaNCT06387615
Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words
A study testing Active cTBS in people with Dyslexia and Dyslexia, Developmental, run by Georgia State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Dyslexia, Developmental, Learning; Developmental Disorder, Reading
- What is being tested?
- Active cTBS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Native English speaker (who is not fluent in any other language and does not identify as bilingual)
- Normal or corrected to normal vision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI)
Atlanta, Georgia, 30318
About this study
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.
Read the detailed description
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.
- Being tested
- Active cTBS, Sham
- Keywords
- word learning, consolidation, vocabulary, artificial lexicon, brain stimulation, transcranial magnetic stimulation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cTBSOther
Active stimulation
ShamOther
Control stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active cTBS | Experimental | Active cTBS will be administered to the left supramarginal gyrus Receives: Other: Active cTBS |
| Sham stimulation | Sham comparator | Sham stimulation will be administered to the left supramarginal gyrus Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately following cTBS
Secondary outcomes (1)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jan 2024
- Primary completion17 Nov 2025
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, C. Nikki Arrington, PhD, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387615
- Sponsor's protocol ID
- H22086
- Other IDs
- 1R21HD108576-01A1
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 15664172Olson 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Non-Invasive Brain Stimulation on Learning and Consolidation of Phonologically Similar Novel Spoken Words
- ClinicalTrials.gov ID
- NCT06387615
- Acronym / sponsor ID
- H22086
- Keywords
- word learning, consolidation, vocabulary, artificial lexicon, brain stimulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cTBS | Experimental | Other: Active cTBSActive cTBS will be administered to the left supramarginal gyrus |
| Sham stimulation | Sham comparator | Other: ShamSham stimulation will be administered to the left supramarginal gyrus |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Native English speaker (who is not fluent in any other language and does not identify as bilingual)
- Normal or corrected to normal vision
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active cTBSActive stimulation | Other | Active cTBS |
| ShamControl stimulation | Other | Sham stimulation |
Primary outcome
Novel Word Learning Task
Time frame: 5-mins post stimulation; 24hrs post stimulation
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.
Pseudoword Discrimination Task
Time frame: Immediately following cTBS
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.
1 secondary outcome
MRI Scan
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 15664172Huang 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.
- BackgroundOlson 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cTBS in people with Dyslexia and Dyslexia, Developmental, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Novel Word Learning Task (time frame: 5-mins post stimulation; 24hrs post stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06387615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.