Clinical trial NCT04041960: Effects of TBS on Reading in Adult Struggling Readers
Official title: Examining the Effects of Theta Burst Stimulation on the Neural Network Associated With Reading in Adult Struggling Readers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Reading Disorder
Dyslexia, Developmental
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Institutes of Health (NIH)
First posted: 2019-08-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in lexical decision making
timeFrame: 10 minutes after TMS
measure: Change in real-word reading efficiency
timeFrame: 5 minutes after TMS
measure: Change in Pseudoword reading efficiency
timeFrame: 5 to 10 minutes after TMS
measure: Change in phonemic decoding
timeFrame: 5 to 10 minutes after TMS
Secondary outcomes:
measure: Change in function of neural reading network
timeFrame: 20 minutes after TMS
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Advanced Brain Imaging
state: Georgia
Study officials:
References: