Recruiting

Noninvasive Stimulation

Sponsor:

Vanderbilt University

Code:

NCT05523505

Conditions

Reading Disability

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Sham intervention

RLN real non-invasive brain stimulation intervention

RLN and CCN real non-invasive brain stimulation intervention

Study Details

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

Study ID

NCT05523505

Start date

Nov 7, 2022

Status verified date

Jul, 2025

Completion date

Sep 10, 2026

Anticipated

Primary completion date

Sep 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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:

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:

1. previous diagnosis of Intellectual Disability;
2. known uncorrectable visual impairment;
3. documented hearing impairment greater than or equal to a 25 dB loss;
4. medical contraindication to MRI procedures (e.g., metal devices);
5. known IQ below 70;
6. a pervasive developmental disorder;
7. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors;
8. recent medical diagnosis of migraines;
9. pregnancy;
10. history of syncope;
11. severe fatigue,
12. bilingualism or low English proficiency;
13. poor reading ability that will prevent completion of the tasks; and
14. comorbid severe psychiatric disorders will be excluded;
15. a personal medical history of stroke or seizures;
16. hair styles that do not allow for proper EEG net fitting, or that pose potential risks for damage to EEG net

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham stimulation

Participants receiving sham stimulation.

experimental: Reading and Language Network (RLN)

Participants receiving real stimulation to the left angular gyrus.

experimental: RLN and CCN

Participants receiving real stimulation to the left dorsolateral prefrontal cortex and left angular gyrus.

Interventions

Sham intervention

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

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

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

Primary outcome measure

  • Change in reading comprehension ability on standardized test measure [ Time Frame: Baseline to 12 months ]
  • Performance in reading comprehension ability on test measure during stimulation session [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

More Information

Sponsor

Vanderbilt University

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University on 2025-08-01.