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

NCT ID: NCT06608680

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2028-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Reading Language Control Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iTBS/Sham

Adults age 18-30 with typical reading and language abilities

Group Type EXPERIMENTAL

iTBS

Intervention Type BEHAVIORAL

Excitatory stimulation of supramarginal gyrus

Sham Stimulation

Intervention Type BEHAVIORAL

Sham stimulation of supramarginal gyrus

cTBS/Sham

Adults age 18-30 with typical reading and language abilities

Group Type EXPERIMENTAL

cTBS

Intervention Type BEHAVIORAL

Inhibitory stimulation to supramarginal gyrus

Sham Stimulation

Intervention Type BEHAVIORAL

Sham stimulation of supramarginal gyrus

Interventions

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iTBS

Excitatory stimulation of supramarginal gyrus

Intervention Type BEHAVIORAL

cTBS

Inhibitory stimulation to supramarginal gyrus

Intervention Type BEHAVIORAL

Sham Stimulation

Sham stimulation of supramarginal gyrus

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Georgia State University

OTHER

Sponsor Role lead

Responsible Party

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Rachael Marie Harrington

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Georgia State University

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachael Harrington, Ph.D. CCC-SLP

Role: CONTACT

404-413-6219

C. Nikki Arrington, Ph.D.

Role: CONTACT

404-385-8621

Facility Contacts

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Rachael Harrington, Ph.D. CCC-SLP

Role: primary

404-413-6219

C. Nikki Arrington, Ph.D.

Role: backup

404-385-8621

Other Identifiers

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H23282

Identifier Type: -

Identifier Source: org_study_id

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