Social-cognitive Functioning: Validation of a New Neuropsychological Test

Not Applicable

Not yet recruiting

• Conditions: Frontotemporal Degeneration (FTD); Lewy Body Dementia (LBD); Alzheimer's Disease (AD)
• Interventions: Other: REALSOCOG; Other: Hetero-questionnaires; Other: BCS

• Registration Number: NCT05558709
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).

Detailed Description

It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Study Start: 2024-06-01
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

For patients:

• Patient aged between 18 and 90 years
• Mini Mental State Examination (MMSE) score greater than or equal to 20
• Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner
• Patient with a neurodegenerative pathology: FTD, AD or LBD.

For caregivers:

• Over 18 years of age
• Regular contact with the patient (≥ 2 times per month)

Exclusion Criteria

For patients:

• Neurological or psychiatric comorbidity
• Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion.
• Opposition to participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	REALSOCOG	Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD))
Patients	BCS	Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD))
Relatives	Hetero-questionnaires	Caregivers or relatives of included patients, having regular contact with the patient (≥ 2 times per month).

Primary Outcome Measures

Name	Time	Method
rate of inappropriate behavioural intentions	1 hour and a half	It is measured by the REALSoCog task through a question asking the participant to specify his behavioral intention in the case where he would have declared his intention to act in front of the social situation presented. These questions are asked for each social situation presented, i.e. for a total of 16 situations

Secondary Outcome Measures

Name	Time	Method
Evaluation of Empathy and emotional reactivity	1 hour and a half	The intensity of emotional empathy and the intensity of emotional reactivity are measured by the question "How much are you affected by the situation? This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.; The valence and congruence of the emotions felt are measured by the question "The emotion you feel at the sight of this situation is: 1 (very negative) to 5 (very positive)". This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
Assessment of Moral cognition	1 hour and a half	The ability to detect moral transgressions, the ability to detect conventional transgressions, and the ability to detect control situations (non-transgressive situations) are measured by the question "Does this situation seem appropriate or inappropriate to you?" asked after each REALSoCog situation. The severity judgment of moral transgressions and the severity judgment of conventional transgressions are measured by the question "How inappropriate does it \[the situation\] seem to you?" asked after each response characterizing the situation presented as inappropriate in REALSoCog.
Assessment of theory of mind	1 hour and a half	The ability to detect the intentionality of an action is measured by the question "Is the behavior of the \[main protagonist in the situation\] intentional? Yes / No". This question is asked for 5 REALSoCog situations.; The ability to characterize the valence of this intention and the average valence of the attributed intentions is measured by the question "In your opinion the intention is: 1 (very malicious) to 5 (very benevolent)". This question is asked for 5 REALSoCog situations.; The ability to infer an affect to others is measured by the question "How does \[main protagonist of the situation\] feel?". This question is asked for 8 REALSoCog situations.; The intensity of the affect attributed to others is measured by the question "How does \[main protagonist of the situation\] feel about \[subject's response to the previous question\]?" This question is asked for 8 REALSoCog situations.

Trial Locations

Locations (1)

Hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France