Brain Stimulation Paired With Structured Language Learning in Adults

NCT07762118 | Recruiting

• 3 other identifiers: GN-001-A20262153GN-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Language Development; Learning

Keywords

transcranial electrical stimulation; tES; transcranial direct current stimulation; tDCS; second language acquisition; language learning; neuromodulation; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Pearson PTE Express overall score

  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 Outcomes (1)

• Incidence of adverse events

  Through the intervention period and follow-up, up to 12 months

Study Arms (2)

Active Stimulation

EXPERIMENTAL

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)

Sham Stimulation

SHAM COMPARATOR

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)

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.

Active Stimulation

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.

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Neuro Inc.: lead

Study Sites (1)

General Neuro, Inc.

Boston, Massachusetts, 02131, United States

RECRUITING

Related Publications (4)

• Balboa-Bandeira Y, Zubiaurre-Elorza L, Ibarretxe-Bilbao N, Ojeda N, Pena J. Effects of transcranial electrical stimulation techniques on second and foreign language learning enhancement in healthy adults: A systematic review and meta-analysis. Neuropsychologia. 2021 Sep 17;160:107985. doi: 10.1016/j.neuropsychologia.2021.107985. Epub 2021 Aug 8.

  PMID: 34371068 BACKGROUND

• Simonsmeier BA, Grabner RH, Hein J, Krenz U, Schneider M. Electrical brain stimulation (tES) improves learning more than performance: A meta-analysis. Neurosci Biobehav Rev. 2018 Jan;84:171-181. doi: 10.1016/j.neubiorev.2017.11.001. Epub 2017 Nov 8.

  PMID: 29128578 BACKGROUND

• Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.

  PMID: 18303984 BACKGROUND

• Meinzer M, Jahnigen S, Copland DA, Darkow R, Grittner U, Avirame K, Rodriguez AD, Lindenberg R, Floel A. Transcranial direct current stimulation over multiple days improves learning and maintenance of a novel vocabulary. Cortex. 2014 Jan;50:137-47. doi: 10.1016/j.cortex.2013.07.013. Epub 2013 Aug 6.

  PMID: 23988131 BACKGROUND

Related Links

• Related Info

Study Officials

• Alec Sheffield, PhD

  General Neuro Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alec Sheffield, PhD

CONTACT

617-657-3348; alec@generalneuro.com

Luke Knoble

CONTACT

luke@generalneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sub-Investigator holds the stimulation assignment and is not masked. Assignment is not disclosed to the Principal Investigator until all outcome data are collected and locked and primary analyses are finalized.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two parallel arms, active tES and sham tES, each paired with the same structured language-learning content. Participants are randomized 1:1, with stratification by site or cohort as applicable.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 13, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)