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Source Monitoring Déficit in Neuropsychiatric Population

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ClinicalTrials.gov Identifier: NCT03886584
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Study Description
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Brief Summary:
the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Other: Monitoring source test Not Applicable

Detailed Description:
Source-monitoring abilities will be measured thanks to reality-monitoring testing (i.e. the ability to distinguish internal-generated events from external ones) and internal-monitoring testing (i.e. the ability to distinguish an imagined source from a performed one). A source-monitoring deficit have been demonstrated in patients with psychiatric conditions such as schizophrenia and seems linked to frontotemporal abnormalities (frontotemporal dysconnectivity and temporal hypoactivity). With a total of 150 patients, the investigators will include 30 patients per group: patients with pre-dementia stage Alzheimer, Alzheimer, Fronto-Temporal dementia, Lewy Body dementia or Parkinson and Bipolar Disorder, with the hypothesis that Bipolar Disorder patients will present less marked deficit. The investigators will recruit 150 healthy controls.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arms
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Source Monitoring Déficit in Neuropsychiatric Population
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with with neuropsychiatric conditions

In this arm, five groups :

  • Patients with DFT, diagnosed according Racovsky criteria
  • Patients with Lewi Body dementia, diagnosed according McKeith criteria
  • Patients with pre-demential Alzheimer, diagnosed according Dubois criteria
  • Patients with Alzheimer, diagnosed according MMSE
  • Patients with bipolar disorder, diagnosed according DSM 5
 Other: Monitoring source test
Internal- and external-monitoring correct responses and inversions
Active Comparator: Healthy subjects
Healthy controls appaired in age, sex and educational level
 Other: Monitoring source test
Internal- and external-monitoring correct responses and inversions


Outcome Measures
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Primary Outcome Measures :
  1. measure source memory performance [ Time Frame: one year ]
    in patients with neuropsychiatric disorders with or without temporal involvement (pre-dementia Alzheimer's disease, Alzheimer's disease - AD, fronto-temporal dementia - DFT, Lewy body dementia - DCL and bipolar disorder - TBP) and healthy volunteers matched in age, gender, and level of education.


Secondary Outcome Measures :
  1. measure the recognition of distractors [ Time Frame: one year ]
    words not presented during the source monitoring test phase but presented during the recall phase. This measure will allow us to avoid that a disturbance invading the working memory or attentional capacities does not compromise the good realization of the task.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who gave their free and informed consent;
  • Men and women;
  • Aged 18 to 80;
  • Having normal or corrected vision;
  • Mastering the French language (read and spoken);
  • All subjects will not have a working memory deficit preventing the test from being passed (MMSE short version):AM patients should have a score of <MMSE <26; Patients with pre-dementia AD will be diagnosed according to Dubois criteria (Dubois et al., 2016); patients with early FTD will be diagnosed according to Rascovsky's criteria (Rascovsky et al., 2011); Patients with DCL will be diagnosed according to McKeith's criteria (McKeith et al., 2005), TBP patients will be diagnosed using DSM 5 criteria (Arlington VA, 2013).

Exclusion Criteria:

  • Inadmissibility of the consent or refusal of the subject.
  • Patients under guardianship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886584


Contacts
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Contact: JEROME BRUNELIN, PHD 00334 37 91 55 65 jerome.brunelin@ch-le-vinatier.fr
Contact: Jean-Michel DOREY, PHD 00334 37 91 52 49 jean-michel.dorey@ch-le-vinatier.fr

Locations
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France
Centre Hospitalier Le Vinatier Recruiting
Bron, Rhône Alpes, France, 69678
Contact: VIAL VERONIQUE    0033437915531    veronique.vial@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: JEROME BRUNELIN, PHD Centre Hospitalier Le Vinatier - CRNL - INSERM
More Information
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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT03886584    
Other Study ID Numbers: 2018-A00584-51
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
Bipolar Disorder
Source-monitoring
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms