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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04041960
Enrollment
28
Registered
2019-08-01
Start date
2019-05-01
Completion date
2021-06-30
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Reading Disorder, Dyslexia, Developmental

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.

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.

Interventions

OTHERTranscranial 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.

Sponsors

Medical University of South Carolina
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
Georgia State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in lexical decision making10 minutes after TMSSubjects 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 efficiency5 minutes after TMSSubjects 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 efficiency5 to 10 minutes after TMSSubjects 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 decoding5 to 10 minutes after TMSSubjects 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.

Secondary

MeasureTime frameDescription
Change in function of neural reading network20 minutes after TMSSubjects 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026