Clinical trial NCT06387615: Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words
Official title: Evaluating the Impact of Non-Invasive Brain Stimulation on Learning and Consolidation of Phonologically Similar Novel Spoken Words
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslexia
Dyslexia, Developmental
Learning; Developmental Disorder, Reading
Keywords: word learning
consolidation
vocabulary
artificial lexicon
brain stimulation
transcranial magnetic stimulation
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Novel Word Learning Task
timeFrame: 5-mins post stimulation; 24hrs post stimulation
measure: Pseudoword Discrimination Task
timeFrame: Immediately following cTBS
Secondary outcomes:
measure: MRI Scan
timeFrame: baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI)
state: Georgia
Study officials:
References:
citation: 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.
citation: 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.