Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorGeneral Neuro Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active transcranial electrical stimulation (tES)
DeviceNon-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)
DeviceSham 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active StimulationExperimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to end of intervention period, up to 10 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 monthsOther outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov