Source-monitoring abilities in people with bipolar disorder and other neuropsychiatric conditions

Source Monitoring Déficit in Neuropsychiatric Population

This project will test whether people with bipolar disorder and several neuropsychiatric conditions have more trouble than matched healthy adults at telling if memories or actions were imagined or actually happened.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hôpital le Vinatier (Academic / other)
• Locations: 1 site (Bron, Auvergne-Rhône-Alpes)
• Trial ID: NCT03886584 on ClinicalTrials.gov

What this trial studies

Researchers will compare source-monitoring performance in diagnostic groups and matched healthy controls using computerized reality-monitoring and internal-monitoring tasks that distinguish internally generated from externally derived events and imagined from performed actions. They plan to enroll five diagnostic groups (pre-dementia Alzheimer’s, Alzheimer’s disease, frontotemporal dementia, Lewy body/Parkinson-related disorders, and bipolar disorder) with 30 patients per group, and recruit 150 healthy controls matched for age, sex, and education. Performance will be related to known frontotemporal abnormalities, with the hypothesis that groups with frontotemporal dysfunction will show larger deficits and bipolar patients will show less marked impairment. Testing is done in person, with screening to exclude individuals with working memory deficits that prevent completing the tasks.

Who should consider this trial

Good fit: Adults aged 18–80 who speak French, have normal or corrected vision, can give informed consent, meet diagnostic criteria for one of the enrolled neuropsychiatric groups, and lack a working-memory impairment that prevents testing are ideal candidates.

Not a fit: People who cannot consent or are under guardianship, have severe working-memory or sensory impairments that prevent task completion, or do not speak French are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the work could clarify which disorders show source-monitoring deficits and help target cognitive rehabilitation or earlier diagnostic strategies.

How similar studies have performed: Prior research has documented source-monitoring deficits in schizophrenia and some dementias and linked these deficits to frontotemporal dysfunction, but applying the same tasks across this set of neuropsychiatric groups together is less commonly done.

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

Where this trial is running

Bron, Auvergne-Rhône-Alpes

• Centre Hospitalier Le Vinatier — Bron, Auvergne-Rhône-Alpes, France (Recruiting)

Study contacts

• Principal investigator: Jerome Brunelin, Phd — Centre Hospitalier Le Vinatier - CRNL - INSERM
• Study coordinator: Jerome Brunelin, Phd

Conditions Psychiatric Disorder; Bipolar Disorder; Source-monitoring