Timing and Facilitation Effects of Theta-Burst Stimulation in the Reading and Language Networks (TAFE)

September 19, 2024 updated by: Rachael Marie Harrington, Georgia State University

Timing and Facilitation Effects of Theta-Burst Stimulation in the Reading and Language Systems

The purpose of this study is to understand how transcranial magnetic stimulation affects how quickly, easily, and accurately a person read. Transcranial magnetic stimulation is a technique that uses magnetic fields to briefly affect how well certain brain regions function. The investigators would like to better understand how long the effects of transcranial magnetic stimulation occur in the reading system and at what point the effect is strongest in this system. The main questions it aims to answer are:

  1. At what point after stimulation are the greatest effects on behavior seen
  2. How excitatory and inhibitory stimulation affect behavior

Researchers will compare stimulation types against a sham condition to see effects on reading and language behavior.

Participants will be asked to

  • undergo reading, language, and cognitive testing
  • receive an MRI
  • receive TMS stimulation
  • perform language, reading, and motor tasks

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Georgia State University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachael Harrington, Ph.D. CCC-SLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects must have a minimum of low average intellectual functioning (>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2; Wechsler, 2011) to be included.
  • Within a normal range of reading skills as >85 on the Test of Word Reading Efficiency - Second Edition (TOWRE-2; Torgesen et al., 2012) and the Woodcock-Johnson IV Tests of Achievement (WJ-IV; Schrank et al., 2014)
  • Individuals with a documented history of learning disability will not be included. This will be determined via demographics questionnaire.
  • Subjects must be between the ages of 18 and 30 to be included. This will be determined via demographics questionnaire.
  • Because reading is critically linked to language, only individuals who are native speakers of English will be included in the study. This will be determined via demographics questionnaire.
  • The reading network is typically localized to the left side of the brain. However, left-handed individuals may have different brain lateralization, introducing an important confound to the study. Therefore, only right-handed individuals will be included in the study. This will be determined via demographics questionnaire.
  • Individuals who have hearing deficits (>25dB at 500+ Hz), visual deficits (>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders) will not be included. This will be determined via CABI Screening Forms and Demographics Questionnaire.
  • Individuals with certain metals in their bodies or with certain health conditions will not be included. If an individual has braces on their 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 they will not be included. This will be determined via CABI Screening forms.
  • Individuals with MRI Screening and Contraindication Forms which do not pass MRI Tech review will not be included.
  • Individuals with TMS Screening Forms which do not pass TMS Tech review will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iTBS/Sham
Adults age 18-30 with typical reading and language abilities
Behavioral: iTBS
Excitatory stimulation of supramarginal gyrus
Behavioral: Sham Stimulation
Sham stimulation of supramarginal gyrus
Experimental: cTBS/Sham
Adults age 18-30 with typical reading and language abilities
Behavioral: Sham Stimulation
Sham stimulation of supramarginal gyrus
Behavioral: cTBS
Inhibitory stimulation to supramarginal gyrus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phonological Decoding Reaction Time
Time Frame: Four time points after each stimulation (20, 40, 60 and 80 minutes after stimulation)
Four time points after each stimulation (20, 40, 60 and 80 minutes after stimulation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgia State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H23282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared via the COINS platform

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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