EEG Microstates Across At-Risk Mental States

NCT06045897 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-09-21

No results posted yet for this study

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

Conditions

Interventions

DEVICE

EEG 64 channels

64-channel EEG in wake and resting conditions for 1h30, with oculogram, electromyogram and electromyogram and electrocardiogram. Five minutes of eyes closed will be used for microstate analysis. 1h30 will be used for the sensorimotor task.

DEVICE

Polysomnography 19 electrodes

Overnight polysomnography with 19 EEG channels and ventilatory polygraphy.

BEHAVIORAL

Light hypnosis

Healthy controls will undergo a 5 min light hypnosis exercise that will be focused on proprioception.

BIOLOGICAL

Biological sampling

Blood samples will be taken for genetic, epigenetic, proteomic, and metabolomic studies.

BEHAVIORAL

Virtual reality

Participants will undergo a virtual reality task using a head-mounted display, and their multidimensional self will be assessed prior to and after the task via the self-reference effect on episodic memory.

DEVICE

Voice recording

A double channel audio recorder will be used during 30 min to assess voice characteristics of all subjects.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER
  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Anton Iftimovici, MD, PhD · GHU Paris Psychiatrie et Neurosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • France

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045897 on ClinicalTrials.gov