NCT05523505 Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults
| NCT ID | NCT05523505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University |
| Condition | Reading Disability |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-11-07 |
| Primary Completion | 2026-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-11-07 with a primary completion date of 2026-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Katherine S. Aboud, PhD
PRINCIPAL INVESTIGATOR
Vanderbilt University
Frequently Asked Questions
Who can join the NCT05523505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Reading Disability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05523505 currently recruiting?
Yes, NCT05523505 is actively recruiting participants. Contact the research team at tess.s.fotidzis@vanderbilt.edu for enrollment information.
Where is the NCT05523505 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05523505 clinical trial?
NCT05523505 is sponsored by Vanderbilt University. The principal investigator is Katherine S. Aboud, PhD at Vanderbilt University. The trial plans to enroll 100 participants.