Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia

Regulatory pathway: because developmental dyslexia and related learning disabilities are considered diseases by the U.S. Food and Drug Administration for purposes of device classification, the investigational use of tES in this study falls within FDA jurisdiction. The study is conducted under the abbreviated investigational device exemption pathway on the basis of an IRB non-significant risk determination under 21 CFR 812.2(b). No IDE number is issued by FDA for a study conducted under this pathway.

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 schools, tutoring centers and clinical practices, or a hybrid of the two. For all pediatric sessions a trained adult, who may be a parent, legal guardian, or a trained study team member such as a tutor or educator, is required to be present and supervising for the duration of each session. Supervisors complete training on electrode placement, device operation, and adverse event recognition before the first session.

The protocol declares a bounded parameter envelope within which specific stimulation parameters, reading instruction methods, 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 pediatric participants the declared envelope permits 0 to 2 mA average absolute current, a maximum current density of 2 mA/cm2 at the electrode contact area, a maximum session duration of 60 minutes subject to a 6000 mC total-charge-per-session ceiling, and a maximum of 30 total sessions per participant. Anticipated session durations are 20 to 30 minutes.

Concurrent structured reading instruction may follow any evidence-based structured literacy method, including Orton-Gillingham-based and Lindamood-Bell approaches.

Reading assessments are administered by qualified practitioners, including reading specialists, certified educators, or other personnel trained in administration of the selected instrument.

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.

Inclusion criteria

• Children aged 7 to 17 years inclusive
• Diagnosed with developmental dyslexia or related reading disability, OR exhibiting reading difficulties consistent with developmental dyslexia (for example, performing below the participant's expected grade level on a standardized reading assessment), as identified by the participant's educator, reading practitioner, caregiver, or clinician. A formal clinical diagnosis is not required for enrollment.
• Concurrently receiving or able to receive structured reading instruction during the intervention period
• Parent or legal guardian able and willing to provide informed permission
• Participant able and willing to provide age-appropriate assent

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 beyond reading-related difficulties that would interfere with assent or study participation
• Any other condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study data