ClinicalTrials.gov record NCT07569445

Auditory EEG and Behavioral Assessments in Individuals With Rett Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Auditory EEG and Behavioral Assessments in Individuals With Rett Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age2 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects brain activity and clinical information from people with Rett syndrome and age- and sex-matched control participants. Participants have a noninvasive EEG while listening to simple sounds. Caregivers of participants with Rett syndrome complete questionnaires and an interview, while control participants complete only a brief demographics questionnaire. Measures are taken at a single study visit (baseline, up to 1 day).

What it is studying. The study tests how the brain of people with Rett syndrome responds to simple sounds by recording EEG and relates those brain activity patterns to clinical features such as communication, daily functioning, and symptom severity.

What the researchers hope to learn. To collect EEG measures of auditory evoked response amplitude and latency and to gather clinical measures (Rett Severity Scale, adaptive behavior, communication, behavior, and health) that together better characterize Rett syndrome and support future scientific and clinical research.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This observational research study is designed to learn more about how the brain processes sound in individuals with Rett syndrome. Participants will complete a noninvasive electroencephalogram (EEG) recording while listening to simple sounds through headphones. In addition, parents or caregivers will complete questionnaires and an interview about the participant's symptoms, communication abilities, daily functioning and overall health. The information collected from this study may help researchers better understand brain activity patterns and clinical features associated with Rett syndrome and support future research efforts.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure
  • Electroencephalogram (EEG) Recording

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Rett Syndrome Participants:
  • 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
  • Neurologically healthy individuals ages 2 years or older
  • Are able to tolerate the noninvasive EEG recording
  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

This study is an observational research project conducted under a broader IRB approved protocol that includes multiple neurodevelopmental and neurodegenerative conditions. The current ClinicalTrials.gov record describes only the Rett syndrome component of the research and reflects the procedures currently being performed for participants with Rett syndrome and age/sex-matched controls. All participants in this study will undergo a noninvasive electroencephalogram (EEG) recording to measure brain responses to auditory stimuli. During the EEG, participants will listen to simple sounds through headphones while brain activity is recorded. No behavioral responses are required during the EEG recording. Parents or caregivers of participants with Rett syndrome will complete questionnaires related to the participant's medical history, Rett syndrome symptoms, communication abilities, daily functioning and overall health. A structured interview may also be conducted with the parent/caregiver to assess adaptive behavior. In addition, a Rett syndrome severity scale may be completed by a clinician or trained member of the research team. Control participants (or their parent/caregiver) will be asked to complete a demographics questionnaire. This study does not involve assignment to a treatment or intervention, and does not involve the use of FDA regulated drugs or devices. Optional procedures described in the umbrella protocol such as Magnetic Resonance Imaging (MRI) studies are not part of the current Rett syndrome workflow and are not included in this study record. The primary purpose of this research is to collect observational brain activity and clinical data to better characterize Rett syndrome and to support future scientific and clinical research.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in one study visit to have a noninvasive EEG while listening to simple sounds through headphones (no behavioral responses required). If the participant has Rett syndrome, a parent or caregiver will complete questionnaires and may take part in a structured interview; a clinician or trained team member may complete a Rett Syndrome Severity Scale. Control participants (or their parent) will complete a demographics questionnaire. The study does not assign treatments or use FDA-regulated drugs or devices; optional MRI procedures are not part of the Rett-focused procedures in this record.

How the study is structured. An observational, case-control, cross-sectional study. People with Rett syndrome and matched control participants each attend a single study visit to have a noninvasive EEG while listening to sounds. Caregivers of participants with Rett complete questionnaires and may take part in a structured interview; a clinician or trained team member may complete a Rett severity scale. No treatments or FDA-regulated drugs/devices are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Rett syndrome

Clinical trials20 trials listed for Rett syndromeEvery trial the registry lists for Rett syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Rett syndrome researchLatest monthly update: September 2026. Includes: Seizure add-on drug. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 31, 2025
Primary completion
August 2027 (estimated)
Study completion
August 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
May 6, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Rochester
Principal investigator
John Foxe, Professor - Department of Neuroscience (SMD)
University of Rochester

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
ClinicalTrials.gov record
The information about a study submitted to ClinicalTrials.gov by its sponsor or investigator. It may change as the study is updated, and it is the source this page reproduces.
Magnetic Resonance Imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
primary purpose
The main reason an interventional study is being done, for example treatment, prevention, diagnosis, supportive care or basic science.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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