[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651721":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"General Neuro Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Active transcranial electrical stimulation (tES)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Device: Sham transcranial electrical stimulation (tES)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","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\u002Fcm2 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"affiliation":5,"role":34},"Alec Sheffield, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","617-657-3348","alec@generalneuro.com",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Luke Knoble","luke@generalneuro.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"General Neuro, Inc.","RECRUITING","Boston","Massachusetts","02131","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-71.05977,42.35843,{"lat":56,"lon":55},[59],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":60},"info@generalneuro.com",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100651721","brain-stimulation-paired-with-structured-reading-instruction-in-children-with-dyslexia-100651721",false,"NCT07762365","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)","Inclusion Criteria:\n\n* Children aged 7 to 17 years inclusive\n* 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.\n* Concurrently receiving or able to receive structured reading instruction during the intervention period\n* Parent or legal guardian able and willing to provide informed permission\n* Participant able and willing to provide age-appropriate assent\n\nExclusion Criteria:\n\n* History of epilepsy or any seizure disorder\n* Active skin disease, open wounds, or significant skin irritation at electrode contact sites\n* Implanted electronic medical devices where stimulation would be contraindicated per device manufacturer guidance or investigator judgment after individual risk assessment\n* Significant cognitive impairment beyond reading-related difficulties that would interfere with assent or study participation\n* Any other condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study data","ALL","7 Years","17 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.\n\nChildren 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.\n\nReading 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.\n\nThe device used in this study is investigational and has not been approved or cleared by the U.S. Food and Drug Administration.",[81,82],"Dyslexia","Reading Disability",[84,85,86,87,88,89,90,91,92],"transcranial electrical stimulation","tES","transcranial direct current stimulation","tDCS","dyslexia","reading fluency","structured literacy","pediatric","neuromodulation","2026-08-08",{"date":95,"type":96},"2026-08-13","ACTUAL",{"date":98,"type":75},"2026-11-01",{"date":100,"type":75},"2032-06-01",{"name":5,"class":6},1]