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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alec Sheffield, PhD
- 電話番号：617-657-3348
- メール：alec@generalneuro.com
研究連絡先のバックアップ
- 名前：Luke Knoble
- メール：luke@generalneuro.com
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02131
- 募集
- General Neuro, Inc.
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コンタクト：
- Alec Sheffield, PhD
- 電話番号：617-657-3348
- メール：info@generalneuro.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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偽コンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Pearson PTE Express overall score
時間枠：Baseline to end of intervention period, up to 8 weeks
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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.
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Baseline to end of intervention period, up to 8 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of adverse events
時間枠：Through the intervention period and follow-up, up to 12 months
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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.
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Through the intervention period and follow-up, up to 12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Alec Sheffield, PhD、General Neuro Inc.
出版物と役立つリンク
一般刊行物
- 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.
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- GN-001-A
- GN-001 (その他の識別子：General Neuro, Inc.)
- 20262153 (その他の識別子：WCG)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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