Auditory EEG and behavioral testing for people with Rett syndrome
Auditory EEG and Behavioral Assessments in Individuals With Rett Syndrome
This project will record noninvasive EEG while people with Rett syndrome and matched controls listen to simple sounds to see how their brains process sound.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT07569445 on ClinicalTrials.gov |
What this trial studies
This observational project records noninvasive EEG while participants with Rett syndrome and age/sex-matched controls listen to simple sounds through headphones. No active behavioral responses are required during the EEG, and parents or caregivers complete questionnaires and may be interviewed about symptoms, communication, daily functioning, and overall health. Clinicians or trained staff may complete a Rett syndrome severity scale, while control participants provide demographic information. The combined EEG and clinical data are collected to characterize auditory brain responses and related clinical features to support future biomarker and therapeutic research.
Who should consider this trial
Good fit: People aged 2 years or older with classic Rett syndrome and a confirmed pathogenic MECP2 variant who are past the regression stage, can tolerate noninvasive EEG, and whose parent or caregiver can provide permission and complete questionnaires are ideal candidates.
Not a fit: Individuals with hearing impairment, medical conditions that prevent safe EEG recording, inability to tolerate EEG procedures, or without a confirmed pathogenic MECP2 variant are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could identify EEG signatures that help track or stratify Rett syndrome and guide future treatment development.
How similar studies have performed: Prior small studies have shown altered EEG and auditory responses in Rett syndrome, so this approach builds on promising but still preliminary biomarker work.
Eligibility criteria
Show full inclusion / exclusion criteria
Rett Syndrome Participants: Inclusion Criteria: * Have a clinical diagnosis of classic Rett syndrome * Have a pathogenic MECP2 genetic variant confirmed via genetic testing * Are past the clinical regression stage * Are within the eligible age range for the study (2 years or older) * Are able to tolerate the noninvasive EEG recording * Parent or caregiver is willing and able to provide parental permission and complete questionnaires and interviews Exclusion Criteria: * Experiences hearing impairment or hearing loss * Presence of medical conditions that would prevent safe participation in EEG recording * Inability to tolerate EEG procedures * Any condition that in the opinion of the investigator would interfere with study participation or data quality Controls Inclusion Criteria: * Neurologically healthy individuals ages 2 years or older * Are able to tolerate the noninvasive EEG recording Exclusion Criteria: * Experiences hearing impairment or hearing loss * Medical history of genetic, neurological, or psychiatric disorders * History of special education services * Inability to tolerate EEG procedures * Any condition that in the opinion of the investigator would interfere with study participation or data quality
Where this trial is running
Rochester, New York
- Center for Advanced Brain Imaging and Neurophysiology, University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.