Clinical trial Recruiting at 1 site Observational Ages 2 and up

Auditory EEG and behavioral testing for people with Rett syndrome

Official title: Auditory EEG and Behavioral Assessments in Individuals With Rett Syndrome

Run by University of Rochester · NCT07569445 · Data updated 2026-11-12

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 typeObservational
Ages2 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversity of Rochester
Academic / other
Locations1 site (Rochester, New York)
StatusRecruiting
StartedJuly 31, 2025
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedMay 6, 2026
Trial IDNCT07569445 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Prior small studies have shown altered EEG and auditory responses in Rett syndrome, so this approach builds on promising but still preliminary biomarker work.

Who can join: the full rules

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 it's running

  • Center for Advanced Brain Imaging and Neurophysiology, University of Rochester Medical Center
    Rochester, New York, United States
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Fenfluramine HCl for Rett Syndrome in a Phase 3 study

    This study tests whether fenfluramine hydrochloride helps people with Rett syndrome when compared to a placebo.

    Recruiting at 40 sites Phase 3 UCB Pharma · Little Rock, Arkansas and 39 other locations · NCT07503444

  • Daily oral vorinostat for girls and young women with Rett syndrome

    This trial will try daily oral vorinostat at two escalating dose levels, using a four-week placebo baseline and an N-of-1 design so each participant serves as her own control, to see if the drug is safe and shows clinical or molecular benefit in girls and young women with typical Rett syndrome.

    Recruiting Phase 1 Unravel Biosciences, Inc. · Medellín · NCT07150013

  • Efficacy of Bionetide for treating Rett syndrome in females

    This study is testing if an oral medication called Bionetide can help improve behavior and communication in girls and young women aged 5 to 20 with Rett syndrome.

    Recruiting at 18 sites Phase 3 Biomed Industries, Inc. · Phoenix, Arizona and 17 other locations · NCT06840496

  • Assessing cognitive function in Rett syndrome patients receiving trofinetide treatment

    This study is testing how well eye-tracking tasks can measure cognitive abilities in people with Rett syndrome who are starting treatment with trofinetide.

    Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06705816

  • Identifying biomarkers in Rett Syndrome

    This study is trying to find specific brain signals in girls with Rett Syndrome to see how they differ from girls without the condition and how these signals relate to the severity of their symptoms over time.

    Recruiting at 6 sites Children's Hospital of Philadelphia · Los Angeles, California and 5 other locations · NCT05932589

  • Gene editing to correct common MECP2 mutations in Rett syndrome

    This project will test CRISPR/Cas9 delivered with AAV to correct common MECP2 mutations in females with Rett syndrome using lab and animal work.

    Recruiting University of Siena · Siena, Siena · NCT05740761

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.