- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523505
Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults
Bridging the Gap Between Brain Network Science and High-definition Non-invasive Brain Stimulation to Develop a Scalable Adult Literacy Intervention
Study Overview
Status
Conditions
Detailed Description
One in five adults in the US are unable to adequately comprehend a sentence. Low literacy is a major public health crisis, with no existing solution: findings from the Programme for the International Assessment of Adult Competencies (PIAAC) reveal that there have been no significant improvements to US national statistics on literacy in the past 30 years. Studies of the survey data reveal that adults with low literacy in the US have in-tact but slow word reading processes and vocabulary, and struggle to comprehend sentences and passages. Rates of poor reading comprehension (RC) ability are especially alarming given that RC ability is strongly predictive of educational outcomes, occupation and wage, health literacy/outcomes, and crime. Through these links, the World Literacy Foundation estimates that the literacy crisis accounts for 2% of the US's GDP annually. The current gold-standard interventions for RC ability are behavioral interventions that focus on cognitive skills found to support RC. However, meta-analyses across interventions show minimal raw gains. Brain research has allowed for the identification of "hidden" RC processes that are not captured by behavioral tests These studies have identified a consistent brain pathway that supports positive RC outcomes. This pathway is a compelling target for brain-based interventions. In particular, recent advances in noninvasive brain stimulation interventions provide a promising route for clinically-meaningful, brain-based treatments. However, brain research in RC has not been translated into an effective brain-based intervention. There is an urgent need for a cutting-edge, non-invasive brain stimulation intervention that will transform the way we approach the clinical treatment of poor RC. The current project will integrate our work in the brain network science of RC and breakthroughs in non-invasive stimulation to address these challenges and develop a brain-based RC intervention.
To accomplish this, the proposed study will invite typical adults with a range of RC ability (good and poor) to participate in three visits to the lab. The rationale for examining adults is to that the current study aims to develop a brain-based intervention (i.e. non-invasive brain stimulation) to treat low literacy in adults, as current behavioral interventions in adults are largely unsuccessful. N=225 participants will come in for three visits; for each visit adults will complete behavioral testing, magnet resonance imaging (MRI), and electroencephalography (EEG). Visit 1 will establish baseline behavior and brain measures of the individual (total visit time of 3.5 hours). Visit 2 will include a behavioral and safe, non-invasive stimulation intervention for the individual (total visit of 3 hours). Stimulation will involve two sessions, one while subjects are in the MRI, and one while subjects are having EEG. Visit 2 will also involve behavioral testing to determine intervention effects. Visit 3 will establish prolonged intervention effects using behavior and brain measures of the individual (total visit of 2.5 hours). Participants will be recruited and randomly assigned to receive one of three non-invasive stimulation interventions, and all will receive a canonical behavioral intervention, so that the smallest subgroup in the study will be N=75, which provides sufficient statistical power (see Statistical Design and Power). All subjects will have typical word reading ability (greater than or equal to 15th percentile), and either good (greater than 25th percentile) or poor (less than or equal to 25th percentile) reading comprehension ability. Non-invasive stimulation subgroups include two stimulation groups distinguished only by electrode placement, and one sham control group. Behavioral intervention involves a short paper/pencil reading comprehension intervention. Each intervention subgroup will be randomly assigned, but with the restriction that the distribution of reading comprehension ability is even across subgroups. This will be accomplished while maintaining double-blind procedures. Collection will begin in Summer 2022 and continue through Fall 2025. Adults will be recruited from the Nashville community. Behavioral testing and MRI (with and without stimulation) will occur at the Vanderbilt Institute for Imaging Science (VUIIS). EEG (with and without stimulation) will occur at the Vanderbilt Kennedy Center.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tess Fotidzis, PhD
- Phone Number: 615-601-1311
- Email: tess.s.fotidzis@vanderbilt.edu
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Katherine S. Aboud, PhD
- Phone Number: 615-322-2793
- Email: katherine.aboud@vanderbilt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham stimulation
Participants receiving sham stimulation.
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Use of the non-invasive brain stimulation device to simulate peripheral experience of stimulation without actually stimulating the brain.
|
Experimental: Reading and Language Network (RLN)
Participants receiving real stimulation to the left angular gyrus and left temporal pole.
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Real non-invasive brain stimulation to the left angular gyrus and left temporal pole using transcranial alternating current stimulation (tACS).
|
Experimental: Cognitive Control Network (CCN)
Participants receiving real stimulation to the bilateral dorsolateral prefrontal cortices.
|
Real non-invasive brain stimulation to the bilateral dorsolateral prefrontal cortex using transcranial alternating current stimulation (tACS).
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Experimental: RLN and CCN
Participants receiving real stimulation to the left dorsolateral prefrontal cortex and left angular gyrus.
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Real non-invasive brain stimulation to the bilateral dorsolateral prefrontal cortex and left angular gyrus using transcranial alternating current stimulation (tACS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in reading comprehension ability on standardized test measure
Time Frame: Baseline to 12 months
|
Stimulation induced change in reading comprehension ability measured by Gates MacGinitie Reading Test:
|
Baseline to 12 months
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Performance in reading comprehension ability on test measure during stimulation session
Time Frame: Baseline to 12 months
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Stimulation induced performance in reading comprehension ability measured by free recall of information learned while reading during stimulation session.
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in brain activations during reading
Time Frame: Baseline to 12 month
|
Stimulation induced change in brain activations during reading as measured by a joint analysis of functional magnetic resonance imaging and electroencephalography.
|
Baseline to 12 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine S. Aboud, PhD, Vanderbilt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220596
- DP5OD031843 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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