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)
Who can join
Ages 7 to 17 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Active transcranial electrical stimulation (tES) (device)
- Sham transcranial electrical stimulation (tES) (device)
Sponsor: General Neuro Inc. · Participants: 60 · Started: Nov 1, 2026
Contact the study team
- Alec Sheffield, PhD · Phone: 617-657-3348
Official record on ClinicalTrials.gov — NCT07762365
Locations in the U.S.
| Massachusetts | General Neuro, Inc., Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.