Effects of TBS on Reading in Adult Struggling Readers

NCT ID: NCT04041960

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-06-30

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.

Conditions

Developmental Reading Disorder; Dyslexia, Developmental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

SMG

Brain region targeted with transcranial magnetic stimulation: superamarginal gyrus

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation (TMS)

Intervention Type: 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.

MTG

Brain region targeted with transcranial magnetic stimulation: middle temporal gyrus

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation (TMS)

Intervention Type: 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.

Vertex

Brain region targeted with transcranial magnetic stimulation (none associated): Vertex

Group Type: ACTIVE_COMPARATOR

Transcranial magnetic stimulation (TMS)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

C. Nikki Arrington

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Advanced Brain Imaging

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40152566 (View on PubMed)

Other Identifiers

H18271

Identifier Type: -

Identifier Source: org_study_id