Brain Stimulation for Dyslexia
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Alec Sheffield, PhD
Principal Investigator
General Neuro Inc.
Are You a Good Fit for This Trial?
This trial is for children ages 7 to 17 who have been diagnosed with dyslexia or significant reading difficulties. Participants must be able to take part in structured reading instruction sessions, either at home or at a study site, under adult supervision.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham transcranial electrical stimulation during structured reading instruction sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments up to 12 months post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Electrical Stimulation (tES)
Trial Overview
The study tests whether using a non-invasive brain stimulation device (transcranial electrical stimulation) during reading lessons helps improve reading skills in children with dyslexia. Kids are randomly assigned to get either real or fake (sham) stimulation while learning.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
General Neuro Inc.
Lead Sponsor
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