Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
General Neuro Inc.
Study ID
NCT07762365
Status
Recruiting
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Conditions

  • Dyslexia
  • Reading Disability

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Active transcranial electrical stimulation (tES) — DEVICE
    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) — DEVICE
    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 Details

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.

Key Dates

First listed
Aug 13, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2031
Completion
Jun 1, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Stimulation
    Participants receive active transcranial electrical stimulation delivered through a non-invasive scalp-mounted headset while completing structured reading instruction. Stimulation amplitude and session duration are selected per cohort from the declared pediatric parameter envelope, with current ramping at session start and end. Sessions are typically 20 to 30 minutes, with a maximum of 30 total sessions per participant. A trained adult supervises every session.
  • Sham Comparator: Sham Stimulation
    Participants receive sham stimulation through the same non-invasive scalp-mounted headset while completing the same structured reading instruction. Sham provides the sensory experience of stimulation onset without sustained current delivery. The specific validated sham approach is selected and documented per cohort. A trained adult supervises every session.

Primary Outcome Measure

Change from baseline in TOWRE-2 Total Word Reading Efficiency index [ Time Frame: Baseline to end of intervention period, up to 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
General Neuro, Inc.BostonMassachusetts02131
Alec Sheffield, PhD
[email protected]
617-657-3348

Find similar trials in Boston, MA

By research site
General Neuro, Inc.· Boston, MA

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