Have you or your loved ones been diagnosed with developmental reading disorder?

You may be eligible to participate in a developmental reading disorder clinical trial.

Have you or your loved ones been diagnosed with developmental reading disorder? You may be eligible to participate in a developmental reading disorder clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Developmental Reading Disorder Clinical Trial in Atlanta GA

NCT04041960 | Interventional

Have you or your loved ones been diagnosed with developmental reading disorder?

You may be eligible to participate in a developmental reading disorder clinical trial.

Have you or your loved ones been diagnosed with developmental reading disorder? You may be eligible to participate in a developmental reading disorder clinical trial.

Recruiting

Male & Female

18 - 50

Years old

This study is looking to recruit 45 Participants

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.

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Details for the study

Brief Title

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

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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Primary

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

Primary

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

Primary

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

Change in function of neural reading network

Subjects 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.

20 minutes after TMS

Study 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