Auditory EEG and Behavioral Assessments in Individuals With Rett Syndrome (NCT07569445) | Clinical Trial Compass
RecruitingNot Applicable
Auditory EEG and Behavioral Assessments in Individuals With Rett Syndrome
United States60 participantsStarted 2025-07-31
Plain-language summary
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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Auditory Evoked Response Amplitude Measured by EEG
Timeframe: Assessed at a single study visit (baseline, up to 1 day)
2
Mean Auditory Evoked Response Latency Measured by EEG
Timeframe: Assessed at a single study visit (baseline, up to 1 day)