Self and Time: Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT02765880

Collaborator

Fondation pour la Recherche Médicale (FRM) (Other)

161

Enrollment

Location

Arms

77.5

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Bipolar Disorder	Other: fMRI Other: EEG	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

161 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders

Actual Study Start Date :

Mar 16, 2017

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy volunteer	Other: fMRI Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics. Other: EEG link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.
Experimental: Patients with schizophrenia	Other: fMRI Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics. Other: EEG link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.
Experimental: Patient with bipolar disorder	Other: fMRI Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics. Other: EEG link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.

Arm

Intervention/Treatment

Experimental: Healthy volunteer

Other: fMRI

Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics.

Other: EEG

link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.

Experimental: Patients with schizophrenia

Other: fMRI

Other: EEG

Experimental: Patient with bipolar disorder

Other: fMRI

Other: EEG

Outcome Measures

Primary Outcome Measures

Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization [After study completion (2 years)]

Secondary Outcome Measures

Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest. [After study completion (2 years)]
- Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering. [After study completion (2 years)]
Comparison of patients with schizophrenia vs. bipolar disorder [During fMRI and EEG sessions]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 18 and 60 years
Affiliation to a social security insurance
Written consent given
Only for patient : DSM criteria for schizophrenia or bipolar disorder

Exclusion Criteria:

Addiction problem
Invalidating visual sensory problems
Neurological history
Pregnancy or breastfeeding
Legal safeguard
Participation in another clinical trial
Contraindication to MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de psychiatrie	Strasbourg		France	67000

Sponsors and Collaborators

University Hospital, Strasbourg, France
Fondation pour la Recherche Médicale (FRM)

Investigators

Principal Investigator: Anne GIERSCH, Strasbourg's University Hospitals - INSERM 1114 Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT02765880

Other Study ID Numbers:

6366

First Posted:

May 9, 2016

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022