Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults

NCT05523505 | Recruiting FDA Device

• 2 other identifiers: 220596DP5OD031843
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Reading Disability

Keywords

Neuroimaging; Adults; Non-invasive Brain Stimulation; Reading; Reading Comprehension

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in brain activations during reading

  Baseline to 12 month

Study Arms (3)

Sham stimulation

SHAM COMPARATOR

Participants receiving sham stimulation.

Device: Sham intervention

Reading and Language Network (RLN)

EXPERIMENTAL

Participants receiving real stimulation to the left angular gyrus.

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.

Device: RLN and CCN real non-invasive brain stimulation intervention

Interventions

Sham intervention DEVICE

Use of the non-invasive brain stimulation device to simulate peripheral experience of stimulation without actually stimulating the brain.

Sham stimulation

RLN real non-invasive brain stimulation intervention DEVICE

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

Reading and Language Network (RLN)

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).

RLN and CCN

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Katherine S. Aboud, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tess Fotidzis, PhD

CONTACT

615-601-1311; tess.s.fotidzis@vanderbilt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 31, 2022
• Study Start: November 7, 2022
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available no more than 6 months after initial publication.
• Access Criteria: Publicly available.

Locations

US (1)