Developmental Reading DisorderNCT04041960
Effects of TBS on Reading in Adult Struggling Readers
A study testing Transcranial magnetic stimulation (TMS) in people with Developmental Reading Disorder and Dyslexia, Developmental, run by Georgia State University at 1 site in United States.
Trial summary
The purpose of this project is to understand how reading is related to brain function. To do this, participants will perform some reading tasks and then have magnetic resonance imaging (MRI) brain scans. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Developmental Reading Disorder, Dyslexia, Developmental
- What is being tested?
- Transcranial magnetic stimulation (TMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 Jun 2021
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must meet the study reading criteria based on their reading and reading-related screening test results
- native speakers of English
- Right handed
- minimum of low average intellectual functioning (SS>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2
Who cannot join
- hearing deficits (>25dB at 500+ Hz), visual deficits (>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders)
- Braces on 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
- TMS or MRI Screening and Contraindication Forms which do not pass technician review
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Advanced Brain Imaging
Atlanta, Georgia, 30318
About this study
Official title: Examining the Effects of Theta Burst Stimulation on the Neural Network Associated With Reading in Adult Struggling Readers
The purpose of this project is to understand how reading is related to brain function. To do this, participants will perform some reading tasks and then have magnetic resonance imaging (MRI) brain scans. Participants will then receive transcranial magnetic stimulation (TMS) to the reading areas of the brain, followed by a second MRI brain scan. This will temporarily activate reading abilities. We want to better understand how the reading system in the brain functions.
Read the detailed description
Subjects will come in for up to 2 sessions, each lasting between 1 - 4 hours. Subjects will complete reading and cognitive tasks associated with reading, and receive TMS as well as 2 MRI brain scans, in order to assess brain regions important to reading.
Initial, basic screening including MRI and TMS safety screening will be conducted over the phone during the recruitment phone call and/or screening forms will be emailed to prospective subjects for their review. Those individuals that qualify will be scheduled for session 1. Session 1 will take between 1 and 3 hours. Subjects who pass health/MRI/TMS screening will complete cognitive/reading screening measures as well as the demographic information survey. They will also be trained on the MRI and TMS procedures. If all screening criteria is met, subjects will be asked to return for a second session which will include the MRI and TMS portions of the study.
Session 2 will take place on a separate day and consist of renewal of the health/MRI/TMS screening forms prior to the MRI scan or TMS administration. The baseline MRI portion of the session will last approximately 1.5 hours including screening, training, and scan time. The MRI scan will be followed by the TMS portion which will last approximately 45 minutes. The post-TMS MRI will take place immediately following the TMS session and will last approximately 45 minutes. Reading assessments will be administered before the baseline MRI and again after TMS stimulation/before post-TMS MRI, each lasting approximately 10 minutes.
- Being tested
- Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Other
The TMS protocol to be used, excitatory intermittent theta burst stimulation (iTBS), has been shown to have minimal risk in children as young as 6 (Hong et al., 2015), as well as adults (Huang et al., 2005). This stimulation paradigm uses a series of theta burst stimulation (TBS) units. Each unit consists of 3 pulses of stimulation given at 50 Hz (Huang et al., 2005). Excitatory iTBS consists of 20 sets of 10 TBS units (2 second duration) repeated every 10 seconds for a total of 190 seconds. One session of excitatory stimulation delivers a total of 600 pulses.
| Study group | Role | What they receive |
|---|---|---|
| SMG | Experimental | Brain region targeted with transcranial magnetic stimulation: superamarginal gyrus Receives: Other: Transcranial magnetic stimulation (TMS) |
| MTG | Experimental | Brain region targeted with transcranial magnetic stimulation: middle temporal gyrus Receives: Other: Transcranial magnetic stimulation (TMS) |
| Vertex | Active comparator | Brain region targeted with transcranial magnetic stimulation (none associated): Vertex Receives: Other: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lexical decision making
Subjects will complete one computerized lexical decision making task before and after TMS stimulation in order to assess change in lexical decision making ability 10mins post stimulation. Subjects will see a word cue on the screen and asked to judge with a button press if the word cue is a "real word" or "not a real word."
Measured: 10 minutes after TMS
Change in real-word reading efficiency
Subjects will complete a timed real word reading task before and after TMS stimulation in order to assess change in word reading ability 5mins post stimulation.; Subjects will read a list of words as quickly and as accurately as possible.
Measured: 5 minutes after TMS
Change in Pseudoword reading efficiency
Subjects will complete a pseudoword reading task before and after TMS stimulation in order to assess change in pseudoword reading ability 5mins post stimulation. Subjects will read a list of pseudowords as quickly and as accurately as possible.
Measured: 5 to 10 minutes after TMS
Change in phonemic decoding
Subjects will complete one computerized lexical phonemic decoding task before and after TMS stimulation in order to assess change in phonemic decoding ability 10mins post stimulation. Subjects will see a non-real word cue on the screen and be asked to judge with a button press if the non-real word cue can be pronounced like ("sounds like") a real word or not a real word.
Measured: 5 to 10 minutes after TMS
Secondary outcomes (1)
Change in function of neural reading network
Subjects will complete a functional MRI task requiring the subject to read a word and identify if it matches a picture present on the screen. This will be used to assess the effectiveness of the TMS on the targeted reading network.
Measured: 20 minutes after TMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 May 2019
- Primary completion30 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Reading DisorderStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, C. Nikki Arrington, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041960
- Sponsor's protocol ID
- H18271
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2019
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available via the Collaborative Informatics and Neuroimaging Suite data exchange
Publications
Herrera-Diaz A, Bledniak E, Harrington RM, Morris R, Arrington CN. Functional Activation following Transcranial Magnetic Stimulation in Neurotypical Adult Readers. J Integr Neurosci. 2025 Mar 20;24(3):26365. doi: 10.31083/JIN26365.
PubMed 40152566
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Theta Burst Stimulation on the Neural Network Associated With Reading in Adult Struggling Readers
- ClinicalTrials.gov ID
- NCT04041960
- Acronym / sponsor ID
- H18271
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, National Institutes of Health (NIH)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 1 Aug 2019 (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 this project is to understand how reading is related to brain function. To do this, participants will perform some reading tasks and then have magnetic resonance imaging (MRI) brain scans. Participants will then receive transcranial magnetic stimulation (TMS) to the reading areas of the brain, followed by a second MRI brain scan. This will temporarily activate reading abilities. We want to better understand how the reading system in the brain functions.
Detailed description
Subjects will come in for up to 2 sessions, each lasting between 1 - 4 hours. Subjects will complete reading and cognitive tasks associated with reading, and receive TMS as well as 2 MRI brain scans, in order to assess brain regions important to reading.
Initial, basic screening including MRI and TMS safety screening will be conducted over the phone during the recruitment phone call and/or screening forms will be emailed to prospective subjects for their review. Those individuals that qualify will be scheduled for session 1. Session 1 will take between 1 and 3 hours. Subjects who pass health/MRI/TMS screening will complete cognitive/reading screening measures as well as the demographic information survey. They will also be trained on the MRI and TMS procedures. If all screening criteria is met, subjects will be asked to return for a second session which will include the MRI and TMS portions of the study.
Session 2 will take place on a separate day and consist of renewal of the health/MRI/TMS screening forms prior to the MRI scan or TMS administration. The baseline MRI portion of the session will last approximately 1.5 hours including screening, training, and scan time. The MRI scan will be followed by the TMS portion which will last approximately 45 minutes. The post-TMS MRI will take place immediately following the TMS session and will last approximately 45 minutes. Reading assessments will be administered before the baseline MRI and again after TMS stimulation/before post-TMS MRI, each lasting approximately 10 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SMG | Experimental | Other: Transcranial magnetic stimulation (TMS)Brain region targeted with transcranial magnetic stimulation: superamarginal gyrus |
| MTG | Experimental | Other: Transcranial magnetic stimulation (TMS)Brain region targeted with transcranial magnetic stimulation: middle temporal gyrus |
| Vertex | Active comparator | Other: Transcranial magnetic stimulation (TMS)Brain region targeted with transcranial magnetic stimulation (none associated): Vertex |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must meet the study reading criteria based on their reading and reading-related screening test results
- native speakers of English
- Right handed
- minimum of low average intellectual functioning (SS>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2
Key exclusion criteria (3 listed)
- hearing deficits (>25dB at 500+ Hz), visual deficits (>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders)
- Braces on 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
- TMS or MRI Screening and Contraindication Forms which do not pass technician 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 |
|---|---|---|
| Transcranial magnetic stimulation (TMS)The TMS protocol to be used, excitatory intermittent theta burst stimulation (iTBS), has been shown to have minimal risk in children as young as 6 (Hong et al., 2015), as well as adults (Huang et al., 2005). This stimulation paradigm uses a series of theta burst stimulation (TBS) units. Each unit consists of 3 pulses of stimulation given at 50 Hz (Huang et al., 2005). Excitatory iTBS consists of 20 sets of 10 TBS units (2 second duration) repeated every 10 seconds for a total of 190 seconds. One session of excitatory stimulation delivers a total of 600 pulses. | Other | MTG, SMG, Vertex |
Primary outcome
Change in lexical decision making
Time frame: 10 minutes after TMS
Subjects will complete one computerized lexical decision making task before and after TMS stimulation in order to assess change in lexical decision making ability 10mins post stimulation. Subjects will see a word cue on the screen and asked to judge with a button press if the word cue is a "real word" or "not a real word."
Change in real-word reading efficiency
Time frame: 5 minutes after TMS
Subjects will complete a timed real word reading task before and after TMS stimulation in order to assess change in word reading ability 5mins post stimulation.; Subjects will read a list of words as quickly and as accurately as possible.
Change in Pseudoword reading efficiency
Time frame: 5 to 10 minutes after TMS
Subjects will complete a pseudoword reading task before and after TMS stimulation in order to assess change in pseudoword reading ability 5mins post stimulation. Subjects will read a list of pseudowords as quickly and as accurately as possible.
Change in phonemic decoding
Time frame: 5 to 10 minutes after TMS
Subjects will complete one computerized lexical phonemic decoding task before and after TMS stimulation in order to assess change in phonemic decoding ability 10mins post stimulation. Subjects will see a non-real word cue on the screen and be asked to judge with a button press if the non-real word cue can be pronounced like ("sounds like") a real word or not a real word.
1 secondary outcome
Change in function of neural reading network
Time frame: 20 minutes after TMS
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 Aug 2021.
- Derived from this study: PubMed 40152566Herrera-Diaz A, Bledniak E, Harrington RM, Morris R, Arrington CN. Functional Activation following Transcranial Magnetic Stimulation in Neurotypical Adult Readers. J Integr Neurosci. 2025 Mar 20;24(3):26365. doi: 10.31083/JIN26365.
- Individual participant dataSharing planned: Yes. IPD will be available via the Collaborative Informatics and Neuroimaging Suite data exchange
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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 Transcranial magnetic stimulation (TMS) in people with Developmental Reading Disorder 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 4 inclusion and 3 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 Aug 2021. 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. 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?
Change in lexical decision making (time frame: 10 minutes after TMS). The study lists 4 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 NCT04041960, which also lists 1 linked publication.
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 Aug 2021.