EEG Microstates Across At-Risk Mental States

NCT06045897 | Recruiting

• 1 other identifier: 2021-A01919-32
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Psychotic Disorders; Autism Spectrum Disorder; Major Depressive Disorder; Schizophrenia

Keywords

electroencephalography; at risk mental state; ultra high risk; first episode psychosis; schizophrenia; autism spectrum disorder; EEG microstates; polysomnography; sensorimotor integration; prosody; hypnosis

Outcome Measures

Primary Outcomes (3)

• Occurrence of EEG microstates

  Average number of times a given microstate occurs per second.

  Three years

• Coverage of EEG microstates

  Percentage of total analysis time spent in a given microstate.

  Three years

• Mean duration of EEG microstates

  Average time during which a given microstate was present in an uninterrupted manner (after temporal smoothing).

  Three years

Secondary Outcomes (67)

• Attention modulation

  Three years

• Cortical excitability and inhibition

  Three years

• Integration of sensory information: amplitudes

  Three years

• Integration of sensory information: latencies

  Three years

• Reaction time

  Three years

Study Arms (6)

Major depressive disorder

EXPERIMENTAL

Major depressive disorder as defined by DSM-5 classification

Device: EEG 64 channels; Device: Polysomnography 19 electrodes; Biological: Biological sampling; Device: Voice recording

Autism spectrum disorder

EXPERIMENTAL

Autism spectrum disorder as defined by DSM-5 classification

Device: EEG 64 channels; Device: Polysomnography 19 electrodes; Biological: Biological sampling; Device: Voice recording

At risk mental state

EXPERIMENTAL

At risk mental state as defined in the CAARMS

Device: EEG 64 channels; Device: Polysomnography 19 electrodes; Biological: Biological sampling; Behavioral: Virtual reality; Device: Voice recording

First episode psychosis

EXPERIMENTAL

Any DSM-5 category associated with psychotic symptoms

Device: EEG 64 channels; Device: Polysomnography 19 electrodes; Biological: Biological sampling; Behavioral: Virtual reality; Device: Voice recording

Schizophrenia

EXPERIMENTAL

Schizophrenia as defined by DSM-5 classification

Device: EEG 64 channels; Device: Polysomnography 19 electrodes; Biological: Biological sampling; Device: Voice recording

Healthy controls

EXPERIMENTAL

Healthy controls with no history of neurodevelopmental disorder or psychotic disorder in a first degree relative

Device: EEG 64 channels; Device: Polysomnography 19 electrodes; Behavioral: Light hypnosis; Biological: Biological sampling; Behavioral: Virtual reality; Device: Voice recording

Interventions

EEG 64 channels DEVICE

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.

At risk mental state; Autism spectrum disorder; First episode psychosis; Healthy controls; Major depressive disorder; Schizophrenia

Polysomnography 19 electrodes DEVICE

Overnight polysomnography with 19 EEG channels and ventilatory polygraphy.

At risk mental state; Autism spectrum disorder; First episode psychosis; Healthy controls; Major depressive disorder; Schizophrenia

Light hypnosis BEHAVIORAL

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

Healthy controls

Biological sampling BIOLOGICAL

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

At risk mental state; Autism spectrum disorder; First episode psychosis; Healthy controls; Major depressive disorder; Schizophrenia

Virtual reality BEHAVIORAL

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.

At risk mental state; First episode psychosis; Healthy controls

Voice recording DEVICE

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

At risk mental state; Autism spectrum disorder; First episode psychosis; Healthy controls; Major depressive disorder; Schizophrenia

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• suicidal risk
• severe or non-stabilized somatic and neurological disorders
• epilepsy
• head trauma
• IQ below 70
• bipolar disorder
• obsessive-compulsive disorder
• substance use disorder, except for cannabis, tolerated up to 5 joints/day.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Centre de Recherche Clinique, Hôpital Sainte-Anne, GHU Paris Psychiatrie et Neurosciences

Paris, 75014, France

RECRUITING

Related Publications (3)

• Iftimovici A, Marchi A, Ferat V, Pruvost-Robieux E, Guinard E, Morin V, Elandaloussi Y, D'Halluin A, Krebs MO, Chaumette B, Gavaret M. Electroencephalography microstates imbalance across the spectrum of early psychosis, autism, and mood disorders. Eur Psychiatry. 2023 May 29;66(1):e41. doi: 10.1192/j.eurpsy.2023.2414.

  PMID: 37246142 BACKGROUND

• Gavaret M, Iftimovici A, Pruvost-Robieux E. EEG: Current relevance and promising quantitative analyses. Rev Neurol (Paris). 2023 Apr;179(4):352-360. doi: 10.1016/j.neurol.2022.12.008. Epub 2023 Mar 10.

  PMID: 36907708 BACKGROUND

• Lucarini V, Alouit A, Yeh D, Le Coq J, Savatte R, Charre M, Louveau C, Houamri MB, Penaud S, Gaston-Bellegarde A, Rio S, Drouet L, Elbaz M, Becchio J, Pourchet S, Pruvost-Robieux E, Marchi A, Moyal M, Lefebvre A, Chaumette B, Grice M, Lindberg PG, Dupin L, Piolino P, Lemogne C, Leger D, Gavaret M, Krebs MO, Iftimovici A. Neurophysiological explorations across the spectrum of psychosis, autism, and depression, during wakefulness and sleep: protocol of a prospective case-control transdiagnostic multimodal study (DEMETER). BMC Psychiatry. 2023 Nov 21;23(1):860. doi: 10.1186/s12888-023-05347-x.

  PMID: 37990173 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Autism Spectrum Disorder; Depressive Disorder, Major; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Anton Iftimovici, MD, PhD

  GHU Paris Psychiatrie et Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anton Iftimovici, MD, PhD

CONTACT

0033(0)145658179; anton.iftimovici@ghu-paris.fr

Valeria Lucarini, MD, MS

CONTACT

0033(0)145658179; valeria.lucarini@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: September 21, 2023
• Study Start: May 30, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)