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

NCT ID: NCT06387615

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

The proposed study is designed to assess the contribution of the dorsal stream of the language network (i.e., left supramarginal gyrus, or SMG) to different aspects of novel word learning in two groups of participants (16-24 years of age): 20 typically developing older youth (OYTD; tested in Aim 1) and 20 older youth with reading difficulties (OYRD; tested in Aim 2). The investigators will use inhibitory continuous theta burst stimulation (cTBS), a well-established repetitive TMS (rTMS) protocol that reduces cortical excitability in a targeted brain region for up to 60 minutes. Participants will complete a baseline magnetic resonance imaging (MRI) session in Week 1, followed by cTBS or sham stimulation to the left SMG, with order of administration counterbalanced across participants. Immediately following cTBS (or sham), participants will complete a visual pseudoword phonological discrimination task and a spoken word learning task. The following day (i.e., 24 hours later), retention of items learned will be measured. In Week 2, cTBS (or sham) will be administered to the left SMG (whichever stimulation was not administered in Week 1) and then the pseudoword discrimination and word learning tasks will be administered using a different set of novel words from those presented in Week 1. Twenty-four hours later, the retention of this second set of items will be measured.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active cTBS

Active cTBS will be administered to the left supramarginal gyrus

Group Type: EXPERIMENTAL

Active cTBS

Intervention Type: OTHER

Active stimulation

Sham stimulation

Sham stimulation will be administered to the left supramarginal gyrus

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

Control stimulation

Interventions

Active cTBS

Active stimulation

Intervention Type: OTHER

Sham

Control stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

C. Nikki Arrington, PhD

Assistant Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

C.Nikki Arrington, PhD

Role: CONTACT

carrington3@gsu.edu

404-385-8621

Facility Contacts

C.Nikki Arrington, PhD

Role: primary

404-385-8621

References

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.

Reference Type: BACKGROUND

PMID: 15664172 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

1R21HD108576-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H22086

Identifier Type: -

Identifier Source: org_study_id