Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia

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.

Conditions

• Dyslexia
• Reading Disability

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• General Neuro Inc.

  lead INDUSTRY

Principal Investigators

• Alec Sheffield, PhD · General Neuro Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-11-01

Primary Completion

2031-06-01

Completion

2032-06-01

FDA Device

Yes

Countries

• United States

Study Locations