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Effects of TBS on Reading in Adult Struggling Readers

Primary Purpose

Developmental Reading Disorder, Dyslexia, Developmental

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (TMS)
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Reading Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Advanced Brain Imaging

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

SMG

MTG

Vertex

Arm Description

Brain region targeted with transcranial magnetic stimulation: superamarginal gyrus

Brain region targeted with transcranial magnetic stimulation: middle temporal gyrus

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

Outcomes

Primary Outcome Measures

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."
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 29, 2019
Last Updated
August 9, 2021
Sponsor
Georgia State University
Collaborators
Medical University of South Carolina, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04041960
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Medical University of South Carolina, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Reading Disorder, Dyslexia, Developmental

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMG
Arm Type
Experimental
Arm Description
Brain region targeted with transcranial magnetic stimulation: superamarginal gyrus
Arm Title
MTG
Arm Type
Experimental
Arm Description
Brain region targeted with transcranial magnetic stimulation: middle temporal gyrus
Arm Title
Vertex
Arm Type
Active Comparator
Arm Description
Brain region targeted with transcranial magnetic stimulation (none associated): Vertex
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in lexical decision making
Description
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."
Time Frame
10 minutes after TMS
Title
Change in real-word reading efficiency
Description
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.
Time Frame
5 minutes after TMS
Title
Change in Pseudoword reading efficiency
Description
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.
Time Frame
5 to 10 minutes after TMS
Title
Change in phonemic decoding
Description
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.
Time Frame
5 to 10 minutes after TMS
Secondary Outcome Measure Information:
Title
Change in function of neural reading network
Description
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.
Time Frame
20 minutes after TMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Center for Advanced Brain Imaging
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available via the Collaborative Informatics and Neuroimaging Suite data exchange
IPD Sharing Time Frame
Data will be made available by January 2022 and will remain in COINS data exchange indefinitely.
IPD Sharing Access Criteria
Request must be made via COINS data exchange
IPD Sharing URL
https://coins.trendscenter.org/

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Effects of TBS on Reading in Adult Struggling Readers

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