Reading Disability Clinical Trial
Official title:
Bridging the Gap Between Brain Network Science and High-definition Non-invasive Brain Stimulation to Develop a Scalable Adult Literacy Intervention
The goal of this project is to address the urgent need for effective, scalable adult literacy interventions by integrating breakthroughs in two separate fields: 1.) the brain network science of resilience to reading disorders and 2.) high-definition non-invasive brain network stimulation. This study will first establish the efficacy of a novel, noninvasive stimulation protocol on reading behavior and brain metrics; then will determine how stimulation-induced effects interact with baseline reading comprehension ability; and lastly, will identify whether stimulation-induced effects are more clinically-beneficial than canonical behavioral interventions. Results may foundationally change how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - This study will be open to all right-handed native English monolingual speakers who meet eligibility criteria regardless of race, gender, minority or socioeconomic status. Due to age-related differences in the language and learning processes, the age range of subjects will be a minimum of 18 years and a maximum of 40 years. Exclusion Criteria: - previous diagnosis of Intellectual Disability; - known uncorrectable visual impairment; - documented hearing impairment greater than or equal to a 25 dB loss; - medical contraindication to MRI procedures (e.g., metal devices); - known IQ below 70; - a pervasive developmental disorder; - any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors; - recent diagnosis of migraines; - pregnancy; - history of syncope; - severe fatigue, - bilingualism or low English proficiency; - poor reading ability that will prevent completion of the tasks; and - comorbid severe psychiatric disorders will be excluded, as will those who are taking psychotropic medications or medications known to increase the risk of seizures or strokes. - participants taking medication known to cause stroke or seizures - hair styles that do not allow for proper EEG net fitting, or that pose potential risks for damage to EEG net |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in reading comprehension ability on standardized test measure | Stimulation induced change in reading comprehension ability measured by Gates MacGinitie Reading Test:
Reading Comprehension Subtest (Adult Reader; AR): Participants have 35 minutes to read passages and answer 48 comprehension questions about what they read. Percentile Ranks based on the scores of entering community college students Primary outcome measure is the change in percentile ranks |
Baseline to 12 months | |
Primary | Performance in reading comprehension ability on test measure during stimulation session | Stimulation induced performance in reading comprehension ability measured by free recall of information learned while reading during stimulation session.
Subject asks to recall content from 100 total sentences Primary outcome measure is the number correct out of total (# recalled / total) compared across groups (real stimulation subgroups and sham). |
Baseline to 12 months | |
Secondary | Change in brain activations during reading | Stimulation induced change in brain activations during reading as measured by a joint analysis of functional magnetic resonance imaging and electroencephalography.
Measures of co-activation in brain areas are obtained for certain timepoints during sentence reading. Typical brain patterns over time are obtained from readers without reading difficulties. The primary outcome measure is a weighting value that reflects how strongly a subject's brain signals align with expected brain signals for typical reading processes. |
Baseline to 12 month |
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