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
Qualifiers
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
Treatments tested in this trial
- Active transcranial electrical stimulation (tES)
- Sham transcranial electrical stimulation (tES)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov