Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words

NCT06387615 | Completed

• 2 other identifiers: H220861R21HD108576-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability.

Conditions

Dyslexia; Dyslexia, Developmental; Learning; Developmental Disorder, Reading

Keywords

word learning; consolidation; vocabulary; artificial lexicon; brain stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Novel Word Learning Task

  The spoken word learning task, completed post-cTBS, will consist of a two-alternative forced choice paradigm in which participants will be presented with two pictures of unusual objects, and will be asked to indicate via button press which picture matches a spoken label. Initial trials require a pure guess, with feedback provided on each trial, and continued until a correct answer is given. Across six learning blocks (24 trials each), participants will learn a set of eight pseudowords total. Twenty-four hours following the initial learning task, participants will be asked to complete two additional learning blocks which will be used to assess retention accuracy. Over the course of the experiment, participants will learn two different sets of items, counter-balanced across participants and groups.

  5-mins post stimulation; 24hrs post stimulation

• Pseudoword Discrimination Task

  The visual pseudoword discrimination task is a computerized forced-choice, reaction time assessment of phonological processing. It measures the participants' ability to phonetically decode a string of letters. This task is simple with high accuracy and has proven highly sensitive to individual differences in phonological decoding skills. Participants are asked to judge via button press whether a visually presented letter string can be pronounced like a 'real word' or not.

  Immediately following cTBS

Secondary Outcomes (1)

• MRI Scan

  baseline

Study Arms (2)

Active cTBS

EXPERIMENTAL

Active cTBS will be administered to the left supramarginal gyrus

Other: Active cTBS

Sham stimulation

SHAM COMPARATOR

Sham stimulation will be administered to the left supramarginal gyrus

Other: Sham

Interventions

Active cTBS OTHER

Active stimulation

Active cTBS

Sham OTHER

Control stimulation

Sham stimulation

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Native English speaker (who is not fluent in any other language and does not identify as bilingual)
• Normal or corrected to normal vision

You may not qualify if:

• Diagnosed with Autism Spectrum Disorder
• Hearing deficits (\>25 decibels at 500+ Hz), visual deficits (\>20/40), serious emotional problems (e.g., severe, uncontrolled depression) and certain neurological conditions (e.g., uncontrolled seizure disorders)
• Individuals with certain metals in their bodies or with certain health conditions. 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
• Individuals taking certain medications that lower seizure threshold
• Individuals with TMS Screening and Contraindication Forms which do not pass TMS Tech review
• Individuals with MRI Screening and Contraindication Forms which do not pass MRI Tech review

Sponsors & Collaborators

• Georgia State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI)

Atlanta, Georgia, 30318, United States

Location

Related Publications (2)

• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

  PMID: 15664172 BACKGROUND

• Olson R, Forsberg H, Wise B, Rack J. Measurement of word recognition, orthographic, and phonological skills. In: Frames of Reference for the Assessment of Learning Disabilities: New Views on Measurement Issues. Paul H. Brookes Publishing Co.; 1994:243-277.

  BACKGROUND

MeSH Terms

Conditions

Dyslexia

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 29, 2024
• Study Start: January 1, 2024
• Primary Completion: November 17, 2025
• Study Completion: January 25, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Timely submission of raw data to repositories will provide an additional layer of safety. Neuroimaging data will be uploaded to COINS in real time. Cleaned behavioral datasets will be uploaded to OSF biannually. Metadata, code, small datasets and links to large datasets used in publications will be archived as supplements or on OSF. Publication specific data will be deposited to the OpenNeuro platform upon publication. All shareable data from this project will be made publicly available no later than the end of the project period, and any data associated with a publication will be made available at the time of publication. The latest point at which data will be provided to the archive is when articles using that data are accepted for publication, or at the conclusion of the project (whichever comes first).
• Access Criteria: Any physical data for this project will be stored within locked filing cabinets for print copies and digital files will be encrypted and stored on password-protected secure servers separately from any participant code keys. Archived data will be stored on a secure server at Georgia State University when primary planned analyses of the data have been completed. The server will be backed up regularly using a tape backup system. The partition where data will sit on the server will not be accessible to anyone outside of the team. Audit trails are maintained for each file to document changes and deletions, and older versions of files are retrievable in the event of unintentional modification.

Locations

US (1)