Clinical Trial

Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia

Recruiting
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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.
Trial Details
NCT Number NCT07762365
Lead Sponsor General Neuro Inc.
Conditions Dyslexia, Reading Disability
Enrollment 60 participants
Start Date 2026-11-01
Primary Completion 2031-06-01 (estimated)
Study Completion 2032-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13