Brain Stimulation Paired With Structured Language Learning in Adults

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
General Neuro Inc.
Study ID
NCT07762118
Status
Recruiting
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Conditions

  • Language Development
  • Learning

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Active transcranial electrical stimulation (tES) — DEVICE
    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.
  • Sham transcranial electrical stimulation (tES) — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 13, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2031
Completion
Jun 1, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active Stimulation
    Participants receive active transcranial electrical stimulation delivered through a non-invasive scalp-mounted headset while completing structured language-learning content. Stimulation amplitude and session duration are selected per cohort from the declared parameter envelope, with current ramping at session start and end. Sessions are typically 20 to 30 minutes.
  • Sham Comparator: Sham Stimulation
    Participants receive sham stimulation through the same non-invasive scalp-mounted headset while completing the same structured language-learning content. Sham provides the sensory experience of stimulation onset without sustained current delivery. The specific validated sham approach is selected and documented per cohort.

Primary Outcome Measure

Change from baseline in Pearson PTE Express overall score [ Time Frame: Baseline to end of intervention period, up to 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
General Neuro, Inc.BostonMassachusetts02131
Alec Sheffield, PhD
[email protected]
617-657-3348

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By research site
General Neuro, Inc.· Boston, MA

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