Timing and Facilitation Effects of Theta-Burst Stimulation in the Reading and Language Networks
TAFE
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 23, 2024
September 1, 2024
4.7 years
September 12, 2024
September 19, 2024
Conditions
Keywords
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
EXPERIMENTALAdults age 18-30 with typical reading and language abilities
cTBS/Sham
EXPERIMENTALAdults age 18-30 with typical reading and language abilities
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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