RecruitingNot ApplicableNCT07762365

Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia

A Study of Transcranial Electrical Stimulation (tES) Paired With Structured Learning Protocols for Accelerated Skill Acquisition: Sub-Protocol B (Pediatric Reading Support for Children With Dyslexia and Reading Disabilities)


Sponsor

General Neuro Inc.

Enrollment

60 participants

Start Date

Nov 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 7 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active transcranial electrical stimulation (tES) and a medical device called Sham transcranial electrical stimulation (tES) for people with dyslexia and reading disability. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive 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.

DEVICESham 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.


Locations(1)

General Neuro, Inc.

Boston, Massachusetts, United States

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NCT07762365


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