An interventional study of Active transcranial electrical stimulation (tES) and Sham transcranial electrical stimulation (tES) in Dyslexia and Reading Disability, sponsored by General Neuro Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by General Neuro Inc. · Not applicable, Interventional, and Treatment
Among 35 studies in Dyslexia with a site in United States — 7 open to participants now, 11 under way, none of them phase 3. Dyslexia · United States.
Among the 35 studies in Dyslexia with a site in United States, this one is the 23rd largest by planned enrollment of the 29 interventional ones, is one of 3 that started in 2026, is one of 24 with no phase, reaches primary completion later than 10 of the 10 other live ones, and was the 35th registered.
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 106 interventional studies indexed under Dyslexia.
Browse Dyslexia studies →7 of the 35 studies in Dyslexia with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 18 Dyslexia studies recruiting now, 2 (11%) set no upper age limit and 14 (78%) stop at 75 or younger; 13 take children under 18; 11 take healthy volunteers.
This study: 7 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →35 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 3 started in 2026.
Median enrollment 160 across the 29 interventional studies, 72 across the 6 observational. Of the 20 that completed or were terminated, 7 (35%) have results posted.
4 of 35 have an industry lead sponsor. The 10 most frequent:
General Neuro Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
General Neuro Inc. has 1 study filed under Dyslexia — fewer than ten, so there is no comparison to draw.
1 of the studies in Dyslexia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02964884Vanderbilt UniversityInterventions for Reading Disabilities in NF1 | 2027-01 |
Among the 35 studies in Dyslexia with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active 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.
Device: Sham 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 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.
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.
Time frame: Baseline to end of intervention period, up to 10 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through the intervention period and follow-up, up to 12 months
Change from baseline in WJ IV Passage Comprehension score
Change in the Passage Comprehension 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 stronger reading comprehension. Analyzed as an exploratory outcome.
Time frame: Baseline to end of intervention period, up to 10 weeks
Plan to share: 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.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jun 2031, 55 months after the start.
Of 69 interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 57. This study's planned 55 months is above that.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Oct 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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General Neuro Inc.