Recruiting

tES

Sponsor:

General Neuro Inc.

Code:

NCT07762365

Conditions

Dyslexia

Reading Disability

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Active transcranial electrical stimulation (tES)

Sham transcranial electrical stimulation (tES)

Study Details

Brief 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

Study ID

NCT07762365

Start date

Nov 1, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2032

Anticipated

Primary completion date

Jun 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 and Locations

Central contacts

Alec Sheffield, PhD

617-657-3348alec@generalneuro.com

Luke Knoble

luke@generalneuro.com

Locations

General Neuro, Inc.

Recruiting

Boston, Massachusetts, United States, 02131

Contacts

Alec Sheffield, PhD

617-657-3348info@generalneuro.com

More Information

Sponsor

General Neuro Inc.

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • transcranial electrical stimulation
  • tES
  • transcranial direct current stimulation
  • tDCS
  • dyslexia
  • reading fluency
  • structured literacy
  • pediatric
  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by General Neuro Inc. on 2026-08-13.