Brain Stimulation Paired With Structured Language Learning in Adults
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Alec Sheffield, PhD
- Número de telefone: 617-657-3348
- E-mail: alec@generalneuro.com
Estude backup de contato
- Nome: Luke Knoble
- E-mail: luke@generalneuro.com
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02131
- Recrutamento
- General Neuro, Inc.
-
Contato:
- Alec Sheffield, PhD
- Número de telefone: 617-657-3348
- E-mail: info@generalneuro.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Falso: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in Pearson PTE Express overall score
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of adverse events
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alec Sheffield, PhD, General Neuro Inc.
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- GN-001-A
- GN-001 (Outro identificador: General Neuro, Inc.)
- 20262153 (Outro identificador: WCG)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .