NCT06608680

Brief Summary

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:

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
May 2023Dec 2028

Study Start

First participant enrolled

May 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

4.7 years

First QC Date

September 12, 2024

Last Update Submit

September 19, 2024

Conditions

Keywords

transcranial magnetic stimulationTMSMRIReadingLanguage

Outcome Measures

Primary Outcomes (1)

  • Phonological Decoding Reaction Time

    Four time points after each stimulation (20, 40, 60 and 80 minutes after stimulation)

Study Arms (2)

iTBS/Sham

EXPERIMENTAL

Adults age 18-30 with typical reading and language abilities

Behavioral: iTBSBehavioral: Sham Stimulation

cTBS/Sham

EXPERIMENTAL

Adults age 18-30 with typical reading and language abilities

Behavioral: cTBSBehavioral: Sham Stimulation

Interventions

iTBSBEHAVIORAL

Excitatory stimulation of supramarginal gyrus

iTBS/Sham
cTBSBEHAVIORAL

Inhibitory stimulation to supramarginal gyrus

cTBS/Sham

Sham stimulation of supramarginal gyrus

cTBS/ShamiTBS/Sham

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Central Study Contacts

Rachael Harrington, Ph.D. CCC-SLP

CONTACT

C. Nikki Arrington, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 23, 2024

Study Start

May 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared via the COINS platform

Locations