- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886584
Source Monitoring Déficit in Neuropsychiatric Population
July 30, 2025 updated by: Hôpital le Vinatier
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JEROME BRUNELIN, PHD
- Phone Number: 00334 37 91 55 65
- Email: jerome.brunelin@ch-le-vinatier.fr
Study Contact Backup
- Name: Jean-Michel DOREY, PHD
- Phone Number: 00334 37 91 52 49
- Email: jean-michel.dorey@ch-le-vinatier.fr
Study Locations
-
-
Rhône Alpes
-
Bron, Rhône Alpes, France, 69678
- Recruiting
- Centre Hospitalier le Vinatier
-
Contact:
- VIAL VERONIQUE
- Phone Number: 0033437915531
- Email: veronique.vial@ch-le-vinatier.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with with neuropsychiatric conditions
In this arm, five groups :
|
Internal- and external-monitoring correct responses and inversions
|
|
Active Comparator: Healthy subjects
Healthy controls appaired in age, sex and educational level
|
Internal- and external-monitoring correct responses and inversions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JEROME BRUNELIN, PHD, Centre Hospitalier Le Vinatier - CRNL - INSERM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2019
Primary Completion (Estimated)
March 8, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 20, 2019
First Posted (Actual)
March 22, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2025
Last Update Submitted That Met QC Criteria
July 30, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A00584-51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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