REtinal and VIsual Cortical Response in Early PSYchosis

NCT05167396 | Terminated

• 2 other identifiers: RIPH 2021-04n° IDRCB 2021-A01700-41
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the REVIPSY study is to measure retinal and the visual cortical electrophysiological responses in situations at risk of psychosis in patients who have experienced a first psychotic episode. A perspective of this project will be to create new electrophysiological biomarkers predictive of the risk of conversion to psychosis

Conditions

Prodromal Schizophrenia; Psychotic Episode; Prodromal Symptoms; Healthy Controls

Keywords

Electrophysiology; Vision; Retina; Visual Cortex; Early psychosis; ERG; EEG

Outcome Measures

Primary Outcomes (4)

• N95 wave

  Amplitude

  Day1

• a wave

  Amplitude

  Day1

• b wave

  Amplitude

  Day1

• P100 wave

  Amplitude

  Day1

Secondary Outcomes (8)

• Visual Object and Space Perception (VOSP)

  Day1

• Verbal Fluency

  Day1

• Working Memory

  Day1

• Betarythm (EEG oscillatory responses)

  Day1

• Contingent Negative Variation (CNV)

  Day1

Study Arms (3)

Healthy Controls (HC)

EXPERIMENTAL

n=90

Device: Retinaute (BioSerenity); Device: EEG Headset 64 electrodes (BioSemi); Device: MonPackOne (Metrovision)

Clinical High Risk of Psychosis (CHRP)

EXPERIMENTAL

n=30

Device: Retinaute (BioSerenity); Device: EEG Headset 64 electrodes (BioSemi)

First Episode Psychosis (FEP)

EXPERIMENTAL

n=30

Device: Retinaute (BioSerenity); Device: EEG Headset 64 electrodes (BioSemi)

Interventions

Retinaute (BioSerenity) DEVICE

Wearable device in the form of a virtual reality headset for the recording of electrophysiological measurements such as electroretinogram (ERG) and electrocenphalogram (EEG), ISCEV standards

Clinical High Risk of Psychosis (CHRP); First Episode Psychosis (FEP); Healthy Controls (HC)

EEG Headset 64 electrodes (BioSemi) DEVICE

EEG headset with 64 electrodes for the recording of visual cortical electrophysiological signals

Clinical High Risk of Psychosis (CHRP); First Episode Psychosis (FEP); Healthy Controls (HC)

MonPackOne (Metrovision) DEVICE

Standard device for the recording of electroretinography (ERG) measurements, ISCEV standards WARNING : Device used only in 3 healthy controls to address the secondary objective

Healthy Controls (HC)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All groups
• Age and gender matching
• Age between 18 and 40
• Enrolled in a social security plan
• Normal or corrected-to-normal visual acuity verified by Monoyer test
• Person who has received and understood prior information about the study
• Person who has given free and informed written consent prior to any participation in the study
• Healthy control group (HC; n=30)
• Met "all groups" criteria
• No current disorders as assessed by the MINI global assessment
• No lifetime (hypo)manic episodes or psychotic disorders and current
• No current or past disorders by CAARMS assessment
• No current disorders according to ICD-10 criteria
• No positive family history (parents/first degree) for affective affective, non-affective psychoses or major affective disorders
• No regular use (more than 3 psychotropic medications: benzodiazepines, hypnotics,antidepressants, antipsychotics or mood regulators or psychostimulants) during the past last 12 months

You may not qualify if:

• Impairment of the subject that makes it difficult or impossible to participate in the or comprehension of the information provided to him/her
• Dyslexia
• Substance use disorder according to CIM-10
• Neurological history including progressive neurological pathology
• Progressive retinal disease
• Chronic glaucoma
• Ophthalmologic pathology affecting visual acuity
• Current ocular infection
• Major under guardianship, curatorship or safeguard of justice
• Pregnant or breastfeeding women
• Persons in a life-threatening emergency situation
• Result of the preliminary medical examination incompatible with the research
• Patient presenting a suicidal risk.
• Criteria incompatible with the use of the Retinaute:
• Allergy to silver

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead
• BioSerenity: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Centre Psychothérapeutique de Nancy

Laxou, 54520, France

Location

Related Publications (7)

• Laprevote V, Heitz U, Di Patrizio P, Studerus E, Ligier F, Schwitzer T, Schwan R, Riecher-Rossler A. [Why and how to treat psychosis earlier?]. Presse Med. 2016 Nov;45(11):992-1000. doi: 10.1016/j.lpm.2016.07.011. Epub 2016 Aug 21. French.

  PMID: 27554461 BACKGROUND

• Demmin DL, Davis Q, Roche M, Silverstein SM. Electroretinographic anomalies in schizophrenia. J Abnorm Psychol. 2018 May;127(4):417-428. doi: 10.1037/abn0000347.

  PMID: 29745706 BACKGROUND

• Moghimi P, Torres Jimenez N, McLoon LK, Netoff TI, Lee MS, MacDonald A 3rd, Miller RF. Electoretinographic evidence of retinal ganglion cell-dependent function in schizophrenia. Schizophr Res. 2020 May;219:34-46. doi: 10.1016/j.schres.2019.09.005. Epub 2019 Oct 12.

  PMID: 31615740 BACKGROUND

• Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. [Retinal investigations in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature]. J Fr Ophtalmol. 2020 Sep;43(7):586-597. doi: 10.1016/j.jfo.2019.10.029. Epub 2020 Jul 4. French.

  PMID: 32631695 BACKGROUND

• Butler PD, Martinez A, Foxe JJ, Kim D, Zemon V, Silipo G, Mahoney J, Shpaner M, Jalbrzikowski M, Javitt DC. Subcortical visual dysfunction in schizophrenia drives secondary cortical impairments. Brain. 2007 Feb;130(Pt 2):417-30. doi: 10.1093/brain/awl233. Epub 2006 Sep 19.

  PMID: 16984902 BACKGROUND

• Knebel JF, Javitt DC, Murray MM. Impaired early visual response modulations to spatial information in chronic schizophrenia. Psychiatry Res. 2011 Sep 30;193(3):168-76. doi: 10.1016/j.pscychresns.2011.02.006. Epub 2011 Jul 20.

  PMID: 21764264 BACKGROUND

• Kim DW, Shim M, Song MJ, Im CH, Lee SH. Early visual processing deficits in patients with schizophrenia during spatial frequency-dependent facial affect processing. Schizophr Res. 2015 Feb;161(2-3):314-21. doi: 10.1016/j.schres.2014.12.020. Epub 2014 Dec 29.

  PMID: 25553978 BACKGROUND

MeSH Terms

Conditions

Schizotypal Personality Disorder; Prodromal Symptoms; Psychotic Disorders

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Vincent LAPRÉVOTE, Pr. MD PhD

  Centre Psychothérapique de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a cross-sectional, open, monocentric, non-randomized study applied in psychiatry and neuroscience. This study will include three groups of adults subject (\>18 years) * Patients with clinical high risk of psychosis (CHRP ; n=30) * Patients having experienced a first psychotic episode (FEP ; n=30) * Healthy Controls (HC ; n=30)

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: December 22, 2021
• Study Start: January 26, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)