Brain Stimulation Paired With Structured Language Learning in Adults
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
Boston, Massachusetts 02131
More Details
- Status
- Recruiting
- Sponsor
- General Neuro Inc.
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.