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RECRUITING
NCT07762118
NA

Brain Stimulation Paired With Structured Language Learning in Adults

Sponsor: General Neuro Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-01

Completion Date

2032-06-01

Last Updated

2026-08-13

Healthy Volunteers

Yes

Interventions

DEVICE

Active 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.

DEVICE

Sham 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