RecruitingNot ApplicableNCT07762118

Brain Stimulation Paired With Structured Language Learning in Adults

A Study of Transcranial Electrical Stimulation (tES) Paired With Structured Learning Protocols for Accelerated Skill Acquisition: Sub-Protocol A (Adult Language Learning)


Sponsor

General Neuro Inc.

Enrollment

60 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates whether transcranial electrical stimulation (tES) delivered during structured language-learning sessions affects the rate and quality of second-language acquisition in adults. Adults who are learning or planning to learn a new language are randomly assigned in equal numbers to receive either active stimulation or sham (placebo) stimulation while completing structured language-learning content. Participants wear a non-invasive transcranial electrical stimulation headset that delivers a low-level electrical current through electrodes resting on the scalp, targeting cortical regions associated with language. Sessions typically last 20 to 30 minutes and may be completed at home or in person at a participating language program. Language proficiency is measured with a standardized assessment before and after the intervention period, with additional app-derived performance metrics and participant-reported measures collected throughout. A follow-up assessment may be conducted up to 12 months after the intervention ends to evaluate whether any observed effects persist. In this study the device is applied as a learning aid in healthy adults. It is not used to diagnose, treat, cure, or prevent any disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active transcranial electrical stimulation (tES) and a medical device called Sham transcranial electrical stimulation (tES) for people with language development and learning. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive transcranial electrical stimulation (tES)

Non-invasive transcranial electrical stimulation delivered by a scalp-mounted headset within the LOTES-2023 limited-output envelope, paired with structured language-learning content. Adult declared range 0 to 4 mA average absolute current, maximum current density 2 mA/cm2 at the electrode contact area, and maximum session duration 60 minutes subject to a 6000 mC per-session total charge limit. Electrodes are placed in standard cephalic or extracephalic montages targeting the left perisylvian region and adjacent association cortex.

DEVICESham transcranial electrical stimulation (tES)

Sham stimulation delivered by the same scalp-mounted headset, providing the initial cutaneous sensory experience of stimulation onset without sustained current delivery, paired with the same structured language-learning content. The specific validated sham approach is selected per cohort and documented in the corresponding cohort plan.


Locations(1)

General Neuro, Inc.

Boston, Massachusetts, United States

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NCT07762118


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