Effects of TBS on Reading in Adult Struggling Readers
Examining the Effects of Theta Burst Stimulation on the Neural Network Associated With Reading in Adult Struggling Readers
1 other identifier
interventional
28
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 16, 2021
August 1, 2021
2 years
July 29, 2019
August 9, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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."
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.
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.
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.
5 to 10 minutes after TMS
Secondary Outcomes (1)
Change in function of neural reading network
20 minutes after TMS
Study Arms (3)
SMG
EXPERIMENTALBrain region targeted with transcranial magnetic stimulation: superamarginal gyrus
MTG
EXPERIMENTALBrain region targeted with transcranial magnetic stimulation: middle temporal gyrus
Vertex
ACTIVE COMPARATORBrain region targeted with transcranial magnetic stimulation (none associated): Vertex
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgia State Universitylead
- Medical University of South Carolinacollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Center for Advanced Brain Imaging
Atlanta, Georgia, 30318, United States
Related Publications (1)
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.
PMID: 40152566DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 29, 2019
First Posted
August 1, 2019
Study Start
May 1, 2019
Primary Completion
April 30, 2021
Study Completion
June 30, 2021
Last Updated
August 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be made available by January 2022 and will remain in COINS data exchange indefinitely.
- Access Criteria
- Request must be made via COINS data exchange
IPD will be available via the Collaborative Informatics and Neuroimaging Suite data exchange