Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia

NCT07762365 · tracked via the Priya Life Science USA tracker

Sponsor

General Neuro Inc.

Phase

Not applicable

Started

2026-11-01

Last updated

2026-08-13

Condition(s) studied

DyslexiaReading Disability

Investigational drug(s) / intervention(s)

Active transcranial electrical stimulation (tES)Sham transcranial electrical stimulation (tES)

Active transcranial electrical stimulation (tES): 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 transcranial electrical stimulation (tES): 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.

Study 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.

Eligibility

Sex

ALL

Min age

7 Years

Max age

17 Years

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
General Neuro, Inc.	Boston	Massachusetts	Recruiting

More General Neuro Inc. trials in the USA

Brain Stimulation Paired With Structured Language Learning in Adults Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07762365 on ClinicalTrials.gov ↗ ← All trials in the USA