Dyslexia, Reading Disability
Conditions
Keywords
transcranial electrical stimulation, tES, transcranial direct current stimulation, tDCS, dyslexia, reading fluency, structured literacy, pediatric, neuromodulation
Brief summary
This study investigates whether transcranial electrical stimulation (tES) delivered during structured reading instruction affects reading proficiency in children with developmental dyslexia and related reading disabilities. Children aged 7 to 17 who have been identified as having dyslexia or reading difficulties are randomly assigned in equal numbers to receive either active stimulation or sham (placebo) stimulation while completing structured reading instruction. Participants wear a non-invasive transcranial electrical stimulation headset that delivers a low-level electrical current through electrodes resting on the scalp. Sessions typically last 20 to 30 minutes and may take place at home or in person at a participating site. A trained adult is present and supervising for every session. Reading proficiency is measured with standardized assessments before and after the intervention period. A follow-up assessment may be conducted up to 12 months after the intervention ends. The device used in this study is investigational and has not been approved or cleared by the U.S. Food and Drug Administration.
Detailed description
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.
Interventions
Non-invasive transcranial electrical stimulation delivered by a scalp-mounted headset within the LOTES-2023 limited-output envelope, paired with structured reading instruction. Pediatric declared range 0 to 2 mA average absolute current, maximum current density 2 mA/cm2 at the electrode contact area, maximum session duration 60 minutes subject to a 6000 mC per-session total charge limit, and a maximum of 30 total sessions per participant. Electrodes are placed in standard cephalic or extracephalic montages targeting cortical regions implicated in reading networks. The device is investigational and is not approved or cleared by the U.S. FDA.
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 reading instruction. The specific validated sham approach is selected per cohort and documented in the corresponding cohort plan.
Sponsors
General Neuro Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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. The trained adult supervising each pediatric session is not informed of assignment.
Intervention model description
Two parallel arms, active tES and sham tES, each paired with the same structured reading instruction. Participants are randomized 1:1, with stratification by site or cohort as applicable.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in TOWRE-2 Total Word Reading Efficiency index | Baseline to end of intervention period, up to 10 weeks | Change in the Total Word Reading Efficiency index of the Test of Word Reading Efficiency, Second Edition (TOWRE-2), a timed measure of word reading efficiency administered by a qualified practitioner. Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate greater word reading efficiency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in CTOPP-2 Phonological Awareness Composite score | Baseline to end of intervention period, up to 10 weeks | Change in the Phonological Awareness Composite score of the Comprehensive Test of Phonological Processing, Second Edition (CTOPP-2), administered by a qualified practitioner. Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate stronger phonological awareness. |
| Change from baseline in CTOPP-2 Rapid Symbolic Naming Composite score | Baseline to end of intervention period, up to 10 weeks | Change in the Rapid Symbolic Naming Composite score of the Comprehensive Test of Phonological Processing, Second Edition (CTOPP-2), administered by a qualified practitioner. Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate faster symbolic naming. |
| Change from baseline in WJ IV Reading Fluency cluster score | Baseline to end of intervention period, up to 10 weeks | Change in the Reading Fluency cluster score of the Woodcock-Johnson IV Tests of Achievement (WJ IV ACH), administered by a qualified practitioner. Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate greater reading fluency. |
| Incidence of adverse events | 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. Adverse events are captured by app-mediated or device-prompted self-report after each session, investigator queries at scheduled assessments, and participant- or supervisor-initiated reports. |
Countries
United States
Contacts
CONTACTAlec Sheffield, PhD
CONTACTLuke Knoble
PRINCIPAL_INVESTIGATORAlec Sheffield, PhD
General Neuro Inc.
Outcome results
None listed