Health TrialsbyHealthPanel

Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults

ConditionReading Disability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorVanderbilt University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham intervention

    Device

    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 intervention

    Device

    Real non-invasive brain stimulation to the left angular gyrus using transcranial alternating current stimulation (tACS).

  • RLN and CCN real non-invasive brain stimulation intervention

    Device

    Real non-invasive brain stimulation to the left dorsolateral prefrontal cortex and left angular gyrus using transcranial alternating current stimulation (tACS).

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Sham stimulationSham comparator 1 intervention
Group B: Reading and Language Network (RLN)Experimental treatment 1 intervention
Group C: RLN and CCNExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to 12 months
2

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).

Time frame
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.

Time frame
Baseline to 12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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