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Brain Stimulation Paired With Structured Language Learning in Adults

7 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02131
        • Werving
        • General Neuro, Inc.
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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-vergelijker: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in Pearson PTE Express overall score
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of adverse events
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

General Neuro Inc.

Onderzoekers

  • Hoofdonderzoeker: Alec Sheffield, PhD, General Neuro Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 juni 2031

Studie voltooiing (Geschat)

1 juni 2032

Studieregistratiedata

Eerst ingediend

3 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 augustus 2026

Eerst geplaatst (Werkelijk)

13 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • GN-001-A
  • GN-001 (Andere identificatie: General Neuro, Inc.)
  • 20262153 (Andere identificatie: WCG)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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