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)
3 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
Study Completion
Last participant's last visit for all outcomes
June 1, 2032
August 13, 2026
August 1, 2026
4.6 years
August 4, 2026
August 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in TOWRE-2 Total Word Reading Efficiency index
Change in the Total Word Reading Efficiency index of the Test of Word Reading Efficiency, Second Edition (TOWRE-2), a timed measure of word reading efficiency administered by a qualified practitioner. Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate greater word reading efficiency.
Baseline to end of intervention period, up to 10 weeks
Secondary Outcomes (4)
Change from baseline in CTOPP-2 Phonological Awareness Composite score
Baseline to end of intervention period, up to 10 weeks
Change from baseline in CTOPP-2 Rapid Symbolic Naming Composite score
Baseline to end of intervention period, up to 10 weeks
Change from baseline in WJ IV Reading Fluency cluster score
Baseline to end of intervention period, up to 10 weeks
Incidence of adverse events
Through the intervention period and follow-up, up to 12 months
Other Outcomes (1)
Change from baseline in WJ IV Passage Comprehension score
Baseline to end of intervention period, up to 10 weeks
Study Arms (2)
Active Stimulation
EXPERIMENTALParticipants 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 Stimulation
SHAM COMPARATORParticipants 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
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Neuro, Inc.
Boston, Massachusetts, 02131, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alec Sheffield, PhD
General Neuro Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The Sub-Investigator holds the stimulation assignment and is not masked. Assignment is not disclosed to the Principal Investigator until all outcome data are collected and locked and primary analyses are finalized. The trained adult supervising each pediatric session is not informed of assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2026
First Posted
August 13, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2032
Last Updated
August 13, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data are not planned to be shared. De-identified study data may be shared with academic collaborators under data sharing agreements, as described in the study protocol.