Brain Stimulation Paired With Structured Language Learning in Adults

August 7, 2026 updated by: General Neuro Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, randomized, double-blind, sham-controlled investigation. Participants are randomized 1:1 to active or sham stimulation, with stratification by site or cohort as applicable. Neither participants nor the research team conducting outcome assessments are aware of assignment during data collection. Stimulation assignment is held by the Sub-Investigator and is not disclosed to the Principal Investigator until all outcome data are collected and locked and primary analyses are finalized.

Sessions may be delivered by decentralized at-home administration, on-site administration at partner language programs and educational institutions, or a hybrid of the two.

The protocol declares a bounded parameter envelope within which specific stimulation parameters, learning content, partner sites, and assessment instruments may be selected per cohort without protocol amendment. All parameters operate within the LOTES-2023 limited-output standard for transcranial electrical stimulation devices. For adult participants the declared envelope permits 0 to 4 mA average absolute current, a maximum current density of 2 mA/cm2 at the electrode contact area, and a maximum session duration of 60 minutes subject to a 6000 mC total-charge-per-session ceiling. Anticipated session durations are 20 to 30 minutes. Any modality within the transcranial electrical stimulation family may be used, including tDCS, tACS, tRNS, and tPCS.

Intended cortical targets are the left perisylvian region and adjacent association cortex, including Broca's area and Wernicke's area. Montages use standard cephalic or extracephalic placements with at least one electrode positioned on the head.

Because assessment instruments and specific stimulation parameters are selected per cohort within the declared envelope, each enrollment cohort has a cohort-specific Statistical Analysis Plan finalized and locked prior to unblinding of that cohort.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • General Neuro, Inc.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Able to understand the consent materials and the informed consent process in English, or in another language for which an IRB-approved consent form is available
  • Willing and able to participate in structured language-learning activities for the duration of the intervention period
  • Able to provide written informed consent

Exclusion Criteria:

  • History of epilepsy or any seizure disorder
  • Active skin disease, open wounds, or significant skin irritation at electrode contact sites
  • Implanted electronic medical devices where stimulation would be contraindicated per device manufacturer guidance or investigator judgment after individual risk assessment
  • Significant cognitive impairment that would interfere with informed consent or study participation
  • Any other condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Pearson PTE Express overall score
Time Frame: Baseline to end of intervention period, up to 8 weeks
Change in the overall score on the Pearson Test of English (PTE) Express, a computer-delivered, remotely proctored assessment of English language proficiency covering listening, reading, speaking, and writing. The overall score is reported on the Global Scale of English and ranges from 10 to 90, with higher scores indicating greater English proficiency.
Baseline to end of intervention period, up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Through the intervention period and follow-up, up to 12 months
Number and severity of adverse events reported, including tingling, itching or warmth under the electrodes, skin redness, headache, fatigue, difficulty sleeping, dizziness or lightheadedness, phosphenes, and skin irritation.
Through the intervention period and follow-up, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Neuro Inc.

Investigators

  • Principal Investigator: Alec Sheffield, PhD, General Neuro Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2032

Study Registration Dates

First Submitted

August 3, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GN-001-A
  • GN-001 (Other Identifier: General Neuro, Inc.)
  • 20262153 (Other Identifier: WCG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be shared. De-identified study data may be shared with academic collaborators under data sharing agreements, as described in the study protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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