Back to resultsSource Monitoring Déficit in Neuropsychiatric Population
Primary Purpose
Psychiatric Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Monitoring source test
Sponsored by
About this trial
This is an interventional basic science trial for Psychiatric Disorder focused on measuring Bipolar Disorder, Source-monitoring
Eligibility 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
Sites / Locations
- Centre Hospitalier Le VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with with neuropsychiatric conditions
Healthy subjects
Arm Description
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
Healthy controls appaired in age, sex and educational level
Outcomes
Primary Outcome Measures
measure source memory performance
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
measure the recognition of distractors
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03886584
Brief Title
Source Monitoring Déficit in Neuropsychiatric Population
Official Title
Source Monitoring Déficit in Neuropsychiatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
Keywords
Bipolar Disorder, Source-monitoring
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arms
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with with neuropsychiatric conditions
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
Healthy controls appaired in age, sex and educational level
Intervention Type
Other
Intervention Name(s)
Monitoring source test
Intervention Description
Internal- and external-monitoring correct responses and inversions
Primary Outcome Measure Information:
Title
measure source memory performance
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
measure the recognition of distractors
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEROME BRUNELIN, PHD
Phone
00334 37 91 55 65
Email
jerome.brunelin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel DOREY, PHD
Phone
00334 37 91 52 49
Email
jean-michel.dorey@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEROME BRUNELIN, PHD
Organizational Affiliation
Centre Hospitalier Le Vinatier - CRNL - INSERM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Rhône Alpes
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Source Monitoring Déficit in Neuropsychiatric Population
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