Source Monitoring Déficit in Neuropsychiatric Population

Psychiatric Disorder Clinical Trial

Official title:

Source Monitoring Déficit in Neuropsychiatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03886584
• Other study ID #: 2018-A00584-51
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Hôpital le Vinatier
• Contact: JEROME BRUNELIN, PHD
• Phone: 00334 37 91 55 65
• Email: jerome.brunelin[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• Monitoring source test
Internal- and external-monitoring correct responses and inversions

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year
Secondary	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.	one year