DyslexiaNCT07762365
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
A study testing Active transcranial electrical stimulation (tES) in people with Dyslexia and Reading Disability, run by General Neuro Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Dyslexia, Reading Disability
- What is being tested?
- Active transcranial electrical stimulation (tES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luke Knoble contact
United States1 site, 1 recruiting
- Recruiting
General Neuro, Inc.
Boston, Massachusetts, 02131
Alec Sheffield, PhD, 617-657-3348, info@generalneuro.com
About this study
Official title: 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)
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.
Read more
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.
Read the detailed description
Regulatory pathway: because developmental dyslexia and related learning disabilities are considered diseases by the U.S. Food and Drug Administration for purposes of device classification, the investigational use of tES in this study falls within FDA jurisdiction. The study is conducted under the abbreviated investigational device exemption pathway on the basis of an IRB non-significant risk determination under 21 CFR 812.2(b). No IDE number is issued by FDA for a study conducted under this pathway.
The study is a prospective, randomized, double-blind, sham-controlled investigation. Participants are randomized 1:1 to active or sham stimulation, with stratification by site or cohort as applicable. Neither participants nor the research team conducting outcome assessments are aware of assignment during data collection. Stimulation assignment is held by the Sub-Investigator and is not disclosed to the Principal Investigator until all outcome data are collected and locked and primary analyses are finalized.
Sessions may be delivered by decentralized at-home administration, on-site administration at partner schools, tutoring centers and clinical practices, or a hybrid of the two. For all pediatric sessions a trained adult, who may be a parent, legal guardian, or a trained study team member such as a tutor or educator, is required to be present and supervising for the duration of each session. Supervisors complete training on electrode placement, device operation, and adverse event recognition before the first session.
The protocol declares a bounded parameter envelope within which specific stimulation parameters, reading instruction methods, partner sites, and assessment instruments may be selected per cohort without protocol amendment. All parameters operate within the LOTES-2023 limited-output standard for transcranial electrical stimulation devices. For pediatric participants the declared envelope permits 0 to 2 mA average absolute current, a maximum current density of 2 mA/cm2 at the electrode contact area, a maximum session duration of 60 minutes subject to a 6000 mC total-charge-per-session ceiling, and a maximum of 30 total sessions per participant. Anticipated session durations are 20 to 30 minutes.
Concurrent structured reading instruction may follow any evidence-based structured literacy method, including Orton-Gillingham-based and Lindamood-Bell approaches.
Reading assessments are administered by qualified practitioners, including reading specialists, certified educators, or other personnel trained in administration of the selected instrument.
Because assessment instruments and specific stimulation parameters are selected per cohort within the declared envelope, each enrollment cohort has a cohort-specific Statistical Analysis Plan finalized and locked prior to unblinding of that cohort.
- Conditions
- Dyslexia, Reading Disability
- Being tested
- Active transcranial electrical stimulation (tES), Sham transcranial electrical stimulation (tES)
- Keywords
- transcranial electrical stimulation, tES, transcranial direct current stimulation, tDCS, dyslexia, reading fluency, structured literacy, pediatric, neuromodulation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | 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. Receives: Device: Active transcranial electrical stimulation (tES) |
| Sham Stimulation | Sham comparator | 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. Receives: Device: Sham transcranial electrical stimulation (tES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of intervention period, up to 10 weeks
Secondary outcomes (4)
Change from baseline in CTOPP-2 Phonological Awareness Composite score
Change in the Phonological Awareness Composite score of the Comprehensive Test of Phonological Processing, Second Edition (CTOPP-2), 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 stronger phonological awareness.
Measured: Baseline to end of intervention period, up to 10 weeks
Change from baseline in CTOPP-2 Rapid Symbolic Naming Composite score
Change in the Rapid Symbolic Naming Composite score of the Comprehensive Test of Phonological Processing, Second Edition (CTOPP-2), 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 faster symbolic naming.
Measured: Baseline to end of intervention period, up to 10 weeks
Change from baseline in WJ IV Reading Fluency cluster score
Change in the Reading Fluency cluster score of the Woodcock-Johnson IV Tests of Achievement (WJ IV ACH), 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 reading fluency.
Measured: Baseline to end of intervention period, up to 10 weeks
Incidence of adverse events
Number and severity of adverse events reported, including tingling, itching or warmth under the electrodes, skin redness, headache, fatigue, difficulty sleeping, dizziness or lightheadedness, phosphenes, and skin irritation. Adverse events are captured by app-mediated or device-prompted self-report after each session, investigator queries at scheduled assessments, and participant- or supervisor-initiated reports.
Measured: Through the intervention period and follow-up, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms, active tES and sham tES, each paired with the same structured reading instruction. Participants are randomized 1:1, with stratification by site or cohort as applicable.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Neuro Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alec Sheffield, PhD, Principal investigator, General Neuro Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762365
- Sponsor's protocol ID
- GN-001-B
- Other IDs
- GN-001, 20262153
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07762365
- Acronym / sponsor ID
- GN-001-B
- Conditions
- Dyslexia, Reading Disability
- Keywords
- transcranial electrical stimulation, tES, transcranial direct current stimulation, tDCS, dyslexia, reading fluency, structured literacy, pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Neuro Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Regulatory pathway: because developmental dyslexia and related learning disabilities are considered diseases by the U.S. Food and Drug Administration for purposes of device classification, the investigational use of tES in this study falls within FDA jurisdiction. The study is conducted under the abbreviated investigational device exemption pathway on the basis of an IRB non-significant risk determination under 21 CFR 812.2(b). No IDE number is issued by FDA for a study conducted under this pathway.
The study is a prospective, randomized, double-blind, sham-controlled investigation. Participants are randomized 1:1 to active or sham stimulation, with stratification by site or cohort as applicable. Neither participants nor the research team conducting outcome assessments are aware of assignment during data collection. Stimulation assignment is held by the Sub-Investigator and is not disclosed to the Principal Investigator until all outcome data are collected and locked and primary analyses are finalized.
Sessions may be delivered by decentralized at-home administration, on-site administration at partner schools, tutoring centers and clinical practices, or a hybrid of the two. For all pediatric sessions a trained adult, who may be a parent, legal guardian, or a trained study team member such as a tutor or educator, is required to be present and supervising for the duration of each session. Supervisors complete training on electrode placement, device operation, and adverse event recognition before the first session.
The protocol declares a bounded parameter envelope within which specific stimulation parameters, reading instruction methods, partner sites, and assessment instruments may be selected per cohort without protocol amendment. All parameters operate within the LOTES-2023 limited-output standard for transcranial electrical stimulation devices. For pediatric participants the declared envelope permits 0 to 2 mA average absolute current, a maximum current density of 2 mA/cm2 at the electrode contact area, a maximum session duration of 60 minutes subject to a 6000 mC total-charge-per-session ceiling, and a maximum of 30 total sessions per participant. Anticipated session durations are 20 to 30 minutes.
Concurrent structured reading instruction may follow any evidence-based structured literacy method, including Orton-Gillingham-based and Lindamood-Bell approaches.
Reading assessments are administered by qualified practitioners, including reading specialists, certified educators, or other personnel trained in administration of the selected instrument.
Because assessment instruments and specific stimulation parameters are selected per cohort within the declared envelope, each enrollment cohort has a cohort-specific Statistical Analysis Plan finalized and locked prior to unblinding of that cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms, active tES and sham tES, each paired with the same structured reading instruction. Participants are randomized 1:1, with stratification by site or cohort as applicable.
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Active transcranial electrical stimulation (tES)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 Stimulation | Sham comparator | Device: Sham transcranial electrical stimulation (tES)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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active Stimulation |
| 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. | Device | Sham Stimulation |
Primary outcome
Change from baseline in TOWRE-2 Total Word Reading Efficiency index
Time frame: Baseline to end of intervention period, up to 10 weeks
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.
4 secondary outcomes
Change from baseline in CTOPP-2 Phonological Awareness Composite score
Time frame: Baseline to end of intervention period, up to 10 weeks
Change from baseline in CTOPP-2 Rapid Symbolic Naming Composite score
Time frame: Baseline to end of intervention period, up to 10 weeks
Change from baseline in WJ IV Reading Fluency cluster score
Time frame: Baseline to end of intervention period, up to 10 weeks
Incidence of adverse events
Time frame: Through the intervention period and follow-up, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luke Knoble contact
Alec Sheffield, PhD principal investigator
General Neuro Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial electrical stimulation (tES) in people with Dyslexia and Reading Disability, run by General Neuro Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alec Sheffield, PhD (617-657-3348, alec@generalneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.