EEG Microstates Across At-Risk Mental States (NCT06045897) | Clinical Trial Compass
RecruitingNot Applicable
EEG Microstates Across At-Risk Mental States
France126 participantsStarted 2023-05-30
Plain-language summary
The goal of this observational study is to compare subjects with at-risk-mental-state, early psychosis, schizophrenia, depression, and autism spectrum disorders, with healthy controls (N = 21 x 6). The main questions it aims to answer are:
* are EEG microstate anomalies associated with diagnosis, clinical and functional prognosis, both in resting conditions and during sleep ?
* are EEG microstates anomalies associated with differences in sensorimotor integration, prosodic and conversational, interoceptive, and narrative self ?
* an ancillary study will be to see whether in healthy controls EEG microstate properties vary under light hypnosis conditions.
Participants will:
* undergo deep phenotyping based on psychopathology and neuropsychological assessments
* undergo a high-resolution EEG (64 electrodes) with a resting period and a sensorimotor task; and healthy controls will have a light hypnosis period.
* undergo a recording of the characteristics of their voice (tone, prosody)
* undergo a one-night polysomnography
* undergo MRI and biological sampling for multi-omic analyses
* undergo a virtual reality experience
Who can participate
Age range
15 Years – 30 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.
Inclusion Criteria:
* age between 15 and 30 years
* subjects meeting CAARMS criteria for stage Ia or Ib mental states at risk (for stage Ia, mild or nonspecific symptoms of psychosis or severe mood disorder, and mild functional impairment; for stage Ib, moderate symptoms below intervention threshold and moderate functional impairment)
* subjects meeting any DSM-5 criteria associated with a first onset of psychotic symptoms (first episode psychosis)
* subjects satisfying DSM-5 criteria for depressive disorder
* subjects meeting DSM-5 criteria for autism spectrum disorder
* healthy control subjects recruited from the general population
Exclusion Criteria:
* suicidal risk
* severe or non-stabilized somatic and neurological disorders
* epilepsy
* head trauma
* IQ below 70
* for healthy control subjects, a family history of psychosis is an exclusion criterion
* bipolar disorder
* obsessive-compulsive disorder
* substance use disorder, except for cannabis, tolerated up to 5 joints/day.
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.