Reading DisabilityNCT05523505
Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults
A study testing RLN real non-invasive brain stimulation intervention and RLN and CCN real non-invasive brain stimulation intervention in people with Reading Disability, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Disability
- What is being tested?
- RLN real non-invasive brain stimulation intervention and RLN and CCN real non-invasive brain stimulation intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- We will exclude individuals with a personal medical history of stroke or seizures or those taking medications specifically prescribed for the treatment of stroke or seizures. However, participants who are on medications that carry an associated risk of stroke or seizures but are not prescribed for these conditions (e.g., anticonvulsants prescribed for pain or behavioral reasons) will remain eligible. Exclusion criteria will be determined by follow-up telephone screenings conducted by lab KSP and is as follows:
- 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;
Show all 17Show fewer
- a pervasive developmental disorder;
- any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors;
- recent medical 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;
- a personal medical history of stroke or seizures;
- hair styles that do not allow for proper EEG net fitting, or that pose potential risks for damage to EEG net
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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 change the foundation for how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.
Read the 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=100 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=30, 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 2026. 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.
- Conditions
- Reading Disability
- Being tested
- Sham intervention, RLN real non-invasive brain stimulation intervention, RLN and CCN real non-invasive brain stimulation intervention
- Keywords
- Neuroimaging, Adults, Non-invasive Brain Stimulation, Reading, Reading Comprehension
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham interventionDevice
Use of the non-invasive brain stimulation device to simulate peripheral experience of stimulation without actually stimulating the brain.
RLN real non-invasive brain stimulation interventionDevice
Real non-invasive brain stimulation to the left angular gyrus using transcranial alternating current stimulation (tACS).
RLN and CCN real non-invasive brain stimulation interventionDevice
Real non-invasive brain stimulation to the left dorsolateral prefrontal cortex and left angular gyrus using transcranial alternating current stimulation (tACS).
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | Participants receiving sham stimulation. Receives: Device: Sham intervention |
| Reading and Language Network (RLN) | Experimental | Participants receiving real stimulation to the left angular gyrus. Receives: Device: RLN real non-invasive brain stimulation intervention |
| RLN and CCN | Experimental | Participants receiving real stimulation to the left dorsolateral prefrontal cortex and left angular gyrus. Receives: Device: RLN and CCN real non-invasive brain stimulation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12 months
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).
Measured: Baseline to 12 months
Secondary outcomes (1)
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.
Measured: Baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start7 Nov 2022
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Katherine Aboud, Vanderbilt University
- Investigators
- Katherine S. Aboud, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523505
- Sponsor's protocol ID
- 220596
- Other IDs
- DP5OD031843
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All research resources and other information developed in this project will be made readily available to the scientific community to support replication of the study's research findings as well as big-data initiatives. Anonymized raw neuroimaging data, demographic data (including age, sex, ethnicity, handedness, and socioeconomic status), and neuroimaging collection parameters will be deposited in the open source data base, NITRC (NeuroImaging Tools and Resources Collaboratory). This will be made publicly available within six months of the initial publication of the data, which we anticipate will occur in year 5 of the proposed research. Other mechanisms for the transfer of information, including research findings and relevant code, will take the form of peer-reviewed publications with links to open source code, posters at scientific conferences and research presentations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap Between Brain Network Science and High-definition Non-invasive Brain Stimulation to Develop a Scalable Adult Literacy Intervention
- ClinicalTrials.gov ID
- NCT05523505
- Acronym / sponsor ID
- 220596
- Conditions
- Reading Disability
- Keywords
- Neuroimaging, Adults, Non-invasive Brain Stimulation, Reading, Reading Comprehension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 change the foundation for how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.
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=100 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=30, 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 2026. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Device: Sham interventionParticipants receiving sham stimulation. |
| Reading and Language Network (RLN) | Experimental | Device: RLN real non-invasive brain stimulation interventionParticipants receiving real stimulation to the left angular gyrus. |
| RLN and CCN | Experimental | Device: RLN and CCN real non-invasive brain stimulation interventionParticipants receiving real stimulation to the left dorsolateral prefrontal cortex and left angular gyrus. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- We will exclude individuals with a personal medical history of stroke or seizures or those taking medications specifically prescribed for the treatment of stroke or seizures. However, participants who are on medications that carry an associated risk of stroke or seizures but are not prescribed for these conditions (e.g., anticonvulsants prescribed for pain or behavioral reasons) will remain eligible. Exclusion criteria will be determined by follow-up telephone screenings conducted by lab KSP and is as follows:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham interventionUse of the non-invasive brain stimulation device to simulate peripheral experience of stimulation without actually stimulating the brain. | Device | Sham stimulation |
| RLN real non-invasive brain stimulation interventionReal non-invasive brain stimulation to the left angular gyrus using transcranial alternating current stimulation (tACS). | Device | Reading and Language Network (RLN) |
| RLN and CCN real non-invasive brain stimulation interventionReal non-invasive brain stimulation to the left dorsolateral prefrontal cortex and left angular gyrus using transcranial alternating current stimulation (tACS). | Device | RLN and CCN |
Primary outcome
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: * 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
Performance in reading comprehension ability on test measure during stimulation session
Time frame: Baseline to 12 months
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).
1 secondary outcome
Change in brain activations during reading
Time frame: Baseline to 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. All research resources and other information developed in this project will be made readily available to the scientific community to support replication of the study's research findings as well as big-data initiatives. Anonymized raw neuroimaging data, demographic data (including age, sex, ethnicity, handedness, and socioeconomic status), and neuroimaging collection parameters will be deposited in the open source data base, NITRC (NeuroImaging Tools and Resources Collaboratory). This will be made publicly available within six months of the initial publication of the data, which we anticipate will occur in year 5 of the proposed research. Other mechanisms for the transfer of information, including research findings and relevant code, will take the form of peer-reviewed publications with links to open source code, posters at scientific conferences and research presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine S. Aboud, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RLN real non-invasive brain stimulation intervention and RLN and CCN real non-invasive brain stimulation intervention in people with Reading Disability, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reading comprehension ability on standardized test measure (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.