NCT04041960

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Georgia State University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Developmental Reading Disorder
• Dyslexia, Developmental

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-04-30
• Completion: 2021-06-30
• First posted: 2019-08-01
• Last updated: 2021-08-16

Locations

1 site across 1 country: United States